Efficacy of B-Cure® Laser therapy for a wide variety of ... · for a wide variety of clinical indications in modern medicine ... implants, orthodontics, root canal treatment,

Efficacy of B-Cure® Laser therapy for a wide variety of clinical indications

in modern medicine

• Clinical Trials • Case Studies • Doctors’ Reviews

1. Introduction ...................................................................................................................................................2

2. Clinical Applications .......................................................................................................................................3

3. Clinical Trials ............................................................................................................................................................. 6

3.1 A new home protocol of LLLT in patients affected by TMJD related pain.

Reasults of randomized, double blind, placebo controlled clinical trial .................................................... 7

3.2 Methodological approaches and the efficiency of Laser therapy

under the b-cure laser dental pro Technology during dental implantation .............................................8

3.3 The “at-home LLLT” in temporo-mandibular disorders pain control: a pilot study .............................. 10

3.4 Effect of Photodynamic Therapy using B-Cure® Laser on an in vitro model of dental plaque ........13

3.5 Analytical report on a pilot study to evaluate the effectiveness and safety of the B-Cure® Laser

medical product for athletes .................................................................................................................................14

3.6 Evaluation of Clinical Data - Low Level Laser therapy Device B-Cure LLLT808 ...................................17

3.7 A cross-sectional post marketing survey to evaluate real-life customer experience

and satisfaction after using the B-cure laser device ......................................................................................18

3.8 Efficacy of low-level laser therapy in the management of neck pain: a systematic review

and meta-analysis of randomised placebo or active-treatment controlled trials ............................... 22

4. Case Studies ................................................................................................................................................. 23

4.1 Case studies - shoulder and upper back ......................................................................................................... 24

4.2 Case studies - lower back ...................................................................................................................................26

4.3 Case studies - elbow ............................................................................................................................................. 31

4.4 Case studies - palm and hand .............................................................................................................................32

4.5 Case studies - hip and groin ..............................................................................................................................36

4.6 Case studies - knees ............................................................................................................................................38

4.7 Case studies - feet ................................................................................................................................................. 42

4.8 Case studies - wounds and skin problems ....................................................................................................46

4.9 Case studies - mouth and jaw ...........................................................................................................................53

5. Doctors’ Reviews ......................................................................................................................................... 58

6. Certificates and Approvals ........................................................................................................................ 66

Index

3

B-Cure® Laser Pro devices are professional medical devices, based on an Israeli development and patent which has made a breakthrough in the field of soft laser technology.Soft laser treatment encourages healing by stimulating the body’s natural cellular activity, strengthening inter cellular communication and stimulating blood circulation. The Results: Reduction of pain and inflammation, while stimulating natural healing and assisting in solving the source of the problem in a comfortable hand held product, without any known side affects.

Technical Advantages:• 808 nm emitting 5 Joules per minute • 4.5 cm² of coherent therapy• 250 mW power and full coherence for effective penetration of the laser deep into the tissues• Laser pulse frequency 13KHz • Effective lifetime of laser diode over 3,000 hours• Laser Class I, medical device class IIa• Effective clinical therapy combined with at-home use, previously seen only in expensive,

full-sized devices

Clinical Applications

1. Introduction

2

54

Wrist

Golf elbow

Thigh

Achilles tendon

Sprained ankle ligament

Toe joints

Back Side

MCL medial lateral ligament

Patellar tendon

Shin

Shoulder

Neck

Trigger Points

Upper back

Finger joints

Lower back

Sciatica

Heel spur

LCL external lateral ligament

Skin injuries

Knees

Hip

Tennis elbow

Recommended treatment points:

B-Cure® Laser Pro

B-Cure® Laser is designed for the treatment of acute and chronic orthopedic problems, pain, inflammation, wounds and sports injuries.

● Significant reduction of pain in cases of - Upper back and lower back pain, neck pain, knee pain, arthritis, tennis elbow, heal spur, Carpal tunnel syndrome, inflammation and joint disorders.● Muscle injury - Muscle strain, partial tear and complete tear.● Tendon wounds and tears - Wound with local haematoma formation, partial and complete tear.● Injury to ligaments - Ligaments strain, partial tear and complete tear.● Cartilage injuries - Chondromalacia, Cartilage damage.● Osseous cartilage damage - Without translocation with covering, full detachment in situ / full detachment ex situ.● Wound healing - Acceleration of the inflammation process, help in collagen synthesis, increase in the tissue’s tensile strength, reduction of healing time and reduction of wound size.

2. Clinical Applications

• Acceleration of healing following dental procedures: extractions, implants, orthodontics, root canal treatment, gum surgeries

• Assists in the treatment of gum inflammation and problems: periodontitis, gingivitis, dentin hypersensitivity

• Helps treating aphthae, herpes, wounds and infections

• Clinically proved to reduce orofacial pain - TMJ /TMD

B-Cure® Laser Dental Pro

Recommended treatment points:

Position the device according to the direction of the beam recommended in the illustration, horizontally or vertically, in keeping with the treatment or medical indication. Place the device outside the mouth, over the area of the treated tooth.

*Tip: For gum disease it is recommended to treat the areas marked with a dotted line.

1 Horizontal position: periodontitis, gingivitis, extractions, inflammation, hypersensitivity, orthodontics, aphthae 2 Vertical position: implants, root canal treatment3 TMJ/TMD / orofacial pain4 Herpes, wounds and infections5 Peripheral point for all indications

2. Clinical Applications

76

Clinical Trials

3. Clinical Trials

Introduction and backgroundStarting from the widely accepted and clinically demonstrated efficacy of the Low Level Laser Therapy in the management of the pain related to TMJD, this study investigated about the possibility to obtain the same positive results with a new home LLLT protocol, based on the self-administration of the therapy. It was designed at a high level in the pyramid of evidence: Randomized, Double blind, Placebo controlled Clinical Trial.

Materials and methods:Patients cohort: 90 consecutive patients affected by TMJD referring at the Department of Oral and Maxillo Facial Sciences of Sapienza, University of Rome randomly sub devided into 3 groups.Study Group (SG) patients (n=30) effective LLLTPlacebo Group (PG) patients (n=30) sham deviceDrug Group (DG) patients (n=30) conventional drug therapyA pain evaluation was requested by examiner immediately before the laser treatment (T0) and at the end of the treatment (T1)For the pain evaluation was adopted the Verbal numeric Scale 0-10.After the treatment all the patients received the conventional therapy for the resolution of the TMJD.

Results:

Conclusion:The LLLT home protocol can be considered an effective and safe method to manage the pain related to TMJDs.Its efficacy is almost equivalent to the conventional drugs therapy.The LLLT has no adverse local or systematic effects.The real extent of the placebo effects need further investigations with larger cohorts of patients and lower number of laser applications.

Del Vecchio A., Fioravanti M., Boccassini A., Di Paolo C., Romeo U.

Department of Oral and Maxillo Facial Sciences

"Sapienza" University of Rome, Italy

T0 T1 Pain Reduction

0

20

60

40

80

LaserPlaceboDrugs

Laser group

Placebo group

Drugs group

Total VNS reduction

340

260

350

3.1 A new home protocol of LLLT in patients affected by TMJD related pain. Results of a randomized, double blind, placebo controlled clinical trial

98

Fig. 8 The magnitude of pain (Vas, scores) and the restructuring of pain symptoms among the patients of compared groups during postoperative dental implantation stages (T2-3 - T10-14)

ABSTRACTIn recent years, dental implantation (DI) firmly maintains the status of the leading trend in modern dentistry [1], being a serious alternative to traditional methods of removable and non- removable prosthesis for dentition defects (DD), providing good aesthetic and functional results and improving patients’ quality of life with respect to the dental sphere [2-8]. The purpose of the study is to assess laser therapy efficiency under the B-Cure Laser Dental Pro technology in terms of preventive, therapeutic and rehabilitation activities for partially edentulous patients during prosthetic treatment stages using dental implants.

Materials And Methods Of ResearchA simple, blind, randomised, single-center, prospective, placebocontrolled clinical trial was conducted during the period of June to October 2016 at the premises of the State Budgetary Health Care Institution of Perm Krai “City Dental Polyclinic No. 2” and the department of therapeutic dentistry and propedeutics of dental diseases at Federal State Budgetary Educational Institution of Higher Education.

Objects of the clinical trial: 30 patients (13 men and 17 women aged 28 to 57) with included dentition defects with different localisation and length, having indications and intentions for prosthetic treatment with the use of structures fixed on dental implants. The groups for comparative placebo-controlled study were created by the limited randomisation method.

Portable laser therapy dental apparatuses of the 5-th generation B-Cure Laser Dental Pro (Good Energies®, Israel) pulse semiconductor (Ga Al As) laser diodes generating infrared laser radiation (wavelength of 808 nm, capacity of 250 mW, pulse frequency of 14 kHz) by the defocused beam of 4.5 cm x 1.0 cm with energy flux density of 14.4 J/min at the peak (3.2 J/ cm2 per min).

Laser therapy procedures were conducted 2-3 days prior to the forthcoming dental implants installation operation. The patient took a comfortable position sitting in the dental chair. After the preliminary antiseptic preparation, the device was applied to the area (one of the six) of root segment (Fig. 5) The device was held on the skin surface during the whole session. On the next day after surgical intervention, the trained patient carried out laser therapy at home, using B-Cure Laser Dental Pro 2 times daily, with duration of 8 minutes (total exposure – 16 minutes), the treatment course lasted 7-10 days.

In overwhelming majority of cases (80.0%), laser therapy with the use of B-Cure Laser Dental Pro, included into the preoperative preparation complex for DI and postoperative management of patients of the control group, prevented local edema and inflammatory complications in the implantation and fascial edema site, 3.3 times less than among the patients of the experimental group.

The professional and home use of B-Cure Laser Dental Pro prevents the development of clinical, functional and aesthetic disorders associated with mouth opening limitation, during the whole surgical stage of DI, whereas all the patients of the experimental group in the setting of placebo laser therapy experienced

early postoperative period of DI (T2-3) being complicated by the problems of mouth opening difficulties and functional and aesthetic disorders associated with this.

According to the RFA data, the use of laser radiation of B-Cure Laser Dental Pro, along with DI, provided the complete osseointegration of all the installed implants, and correspondingly, the success of the DI surgical stage in 100% of cases.

Conclusion:The application of laser therapy of B-Cure Laser Dental Pro before and after dental implantation surgery : • Reduces the detection frequency and intensity of pain symptoms by 3.5 times on the first days after

the installation of intraosseous implants.• Promotes its early and full relief without administering additional painrelieving medication within the

first 5 days of the postoperative period as compared to placebo laser therapy.• Reduces the incidence, duration, and intensity of local edematous and inflammatory processes in the

peri-implant area and soft facial tissues by 3.3-3.7 times.• Provides the efficient prevention of postoperative sensory, paresthetic, and neurological disorders in

the maxillofacial region.• Prevents the development of clinical, functional, and aesthetic disorders associated with limited mouth

opening throughout the whole surgical stage of DI.• Increasing the stability and successful osseointegration of endosseous implants according to the data

of resonance frequency and roentgenologic analysis.• Effective relief of edematous and pain, sensory and paresthetic symptoms, as well as the related

aesthetic, functional and psychological disorders in the settings of laser therapy by B-Cure Laser Dental Pro apparatus allows to minimize subjective feelings of the reduced quality of life and efficiently (p <0,05) lower its objective indicators according to ΣOHIP-49-RU in the early postoperative period.

The findings of the conducted study in terms of objectification of analgesic, anti- inflammatory, decongestant effect of laser therapy with B-Cure Laser Dental Pro optimising the conditions of reparative regeneration of tissues of peri-implant complex, demonstrate the possibility of expanding the indications for its use in dental practice, opens the prospects for inclusion in the treatment complex of inflammatory diseases and mucous mouth membrane, TMJ, endodontic, dental and neurological diseases, traumatic injuries of organs and tissues of the maxillofacial area. We are going to proceed with our research in this direction.

3.2 Methodological approaches and the efficiency of Laser therapy under the b-cure laser dental pro Technology during dental implantation

3.2 Methodological approaches and the efficiency of Laser therapy under the b-cure laser dental pro Technology during dental implantation

3. Clinical Trials 3. Clinical Trials

The State Budgetary Health Care Institution of Perm Krai “City Dental Polyclinic No. 2” and the department of therapeutic dentistry and propedeutics of dental diseases at Federal State Budgetary Educational Institution of Higher Education.

1110

Fornaini C (1), Pelosi A (1), Queirolo V (1), Vescovi P (1) and Merigo E (1) 1) Department of Biomedical, Biotechnological and Translational Sciences (S.Bi.Bi.T.), University of Parma, Italy

ABSTRACT

Objectives: The Temporo-Mandibular Disorders (TMD) are a set of dysfunctional patterns concerning the temporo-mandibular joints (TMJ) and the masticatory muscles; its main symptom is pain, probably caused by inflammatory changes in the synovial membrane, alterations in the bone marrow of the mandibular condyle and impingement and compression. The aim of this preliminary study was to investigate the effectiveness in the TMD pain reduction of a new laser device recently proposed by the market that, due to its reduced dimensions and to be a class I laser according the ANSI classification, may be used at home by the patient himself.

Material and Methods: Twenty-four patients with TMD were randomly selected: the inclusion criteria for the sample was the diagnosis of mono- or bi-lateral TMD, with acute pain restricted to the joint area, associated with the absence of any muscle tenderness during palpation. The patients were randomly assigned to two groups: Group 1 (12 patients): patients receiving real LLLT (experimental group). Group 2 (12 patients): patients receiving inactive laser (placebo group). The treatment was performed once a day for two weeks with a 808 nm diode laser by the patient himself by irradiation of the cutaneous zone corresponding to the TMJ for 15 minutes each side. Each patient was instructed to express its pain in a visual analogue scale (VAS) making a perpendicular line between the two extremes representing the felt pain level. Statistical analysis was realized with GraphPad Instat Software, where P<0.05 was considered significant and P<0.01 very significant.

Results: The patient’s pain evaluation was expressed in the two study groups before the treatment, 1 week and two weeks after the treatment. The differences between the two groups result extremely significant with p<0.0001 for the comparison of VAS value after 1 and 2 weeks.

Conclusions: This study, even if it may be considered such a pilot study due to its limits (number of patients, number of data recorded, subjective evaluations), investigated a new way to control the pain in the temporo-mandibular diseases by a at home self administered laser device. Results are encouraging but they will have to be confirmed by more enlarged studies.

3.3 The “at-home LLLT” in temporo-mandibular disorders pain control: a pilot study

3. Clinical Trials


3. Clinical Trials

Laser group

Placebo group

before treatment

1 week after treatment

2 weeks after treatment

Pain

Lev

el (V

AS)

Table 1: results of the patients pain evaluation expressed as mean of VAS and standard deviation (SD)

1312


3. Clinical Trials

Prof. Lior Shapira, Chair, Department of PeriodontologyHebrew University, Hadassah, Faculty of Dental Medicine, 7/3/2015

Aim:To test the disinfection properties of B-CURE® laser as a solo treatment, or as adjunctive with bio-synthesizer Indocyanin green, in a model of pathogenic biofilm.

Materials and methods:In an in vitro model, pathogenic biofilm was established using non-pathogenic bacteria – Streptococcus sanguis and Actinomyces naslundii and pathogenic bacteria – Porphyromonas gingivalis and Fusobacterium nucleatum on tooth like surfaces (hydroxyapatite discs). The infected discs were exposed to B-CURE® laser with or without pretreatment with Indocyanin green. Control groups will include not treated biofilm and sham treatment (blank laser machine). All groups underwent staining for live and dead bacteria using florescent dyes (Figure 1) and analysis was done using a florescent microscopy.

Results:1. Part AEffect of B-Cure® Laser with and without Indocyanin green - kinetics: We screened different exposure time intervals of exposure to the B-Cure® Laser, either alone or in conjunction with indocyanin green pre-treatment. This was done in order to single out the most effective time point for further experiments. 1a. Short-term Kinetics: Time points included 30 seconds, 60 seconds and 120 seconds. Control group was not exposed to B-Cure® Laser at all. Results of this experiment revealed that the optimum exposure time for visible effect is 120 seconds (Figure 3). Also, the ICS group at 120 seconds exposure showed significant elevation in bacterial death compared with the other groups.

3. Clinical Trials

3.4 Effect of Photodynamic Therapy using B-Cure® Laser on an in vitro model of dental plaque

1514

Federal Biomedical AgencyFederal Public Health Institution, Federal Research and Clinical Centre of Sports Medicine and Rehabilitation of the Federal Biomedical Agency

Approved by:Director of Federal Biomedical Agency of Russian Federal Public Health Institution, Federal Research and Clinical Centre of Sports Medicine and Rehabilitation of the Federal Biomedical Agency Dr.med.Moscow, Russia, 2015

Research aim:To evaluate clinical effectiveness and safety of the B-Cure® Laser medical devices in high-performing athletes.

Research objectives:To assess the impact of clinical effectiveness and safety of the B-Cure® Laser medical device on the symptoms and progress of osteoarthritis of the knee joint, using a visual analogue scale (VAS) and a verbal rating scale.

Osteoarthritis is a common disease with 10% of the population worldwide suffering from it. According to various authors, the incidence of this pathology among other orthopaedic diseases ranges between 30% and 55%. At the same time, it is known that knee joints are most frequently affected (10%) in over 55s, where one in four becomes severely disabled.

Gonarthrosis often occurs in young, able-bodied people, including those engaged in sports and active employment. According to our data, 58% of patients with gonarthrosis who underwent joint replacement were under 60 years old. Therefore, the problem of effective treatment of gonarthrosis is not only medically and socially but also economically significant.

The members of Russian national teams in various sports were involved in the study. The following sports were represented in the study:Football – 10 athletes, Rugby – 6 athletes,Greco-Roman wrestling – 2 athletes,Basketball – 2 athletes.

Inclusion criteria:Patient’s signed informed consent.Over the age of 18.Osteoarthritis of the knee joint.Knee joint injury.Condition after surgery.Intention to receive therapy and all required treatments during the study.

3. Clinical Trials

3.5 Analytical report on a pilot study to evaluate the effectiveness and safety of the B-Cure® Laser medical product for athletes

Description of useThe device was used continuously. Mode of use and optimal exposure mode: the device was put into continuous operation with eight minutes of exposure. The course of treatment was 14 days, excluding weekends (Saturday and Sunday).Depending on the severity of clinical symptoms, the course of treatment may be repeated, if recommended by a doctor.

Staged research findingsThe study was conducted in three stages:Initial assessment of the musculoskeletal system: generally accepted methods of clinical muscle and joint examination used in orthopaedics / traumatology and physical therapy;Questionnaire assessment scales for pain severity on a visual analogue scale (VAS), and pain severity on a verbal rating scale: At this stage of the study, the following has been identified:80% of the athletes studied protected the injured limb when standing and walking, complained of pain and unsteadiness in the affected knee joint; 90% of the subjects noted functional reduction in the strength of the gluteal muscle group on the homolateral side of the affected knee joint; As a result of the primary assessment of the musculoskeletal system, all patients identified pronounced pain and reduction in the movement trajectory of the lower limb when assessed in that area;The second stage of the study was carried out after the B-Cure® Laser medical device was used for seven days: pain reduction in all patients by 30% improvement in the coordination of the affected lower lim. Three athletes, receiving a concurrent course of physical therapy as a part of their rehabilitation programme, noticed a sense of “lightness” and a reduction in pain during physical therapy exercises.

By the end of the course (on the 14th day of the use of the B-Cure® Laser medical device), all athletes showed a significant increase in fluidity and coordination of movement in the affected knee joint. This result suggests an improvement in the adaptation of various structures of the knee joint to physical stress in the subjects.

Table 1: Allocation of patients taking part in the study

3. Clinical Trials

Allocation Average age (years)

Gender M / F (total number)

Initial assessment

Assessment after 7 day useof B-Cure® Laser

Assessment after 14 day useof B-Cure® Laser

Median pain score on the VAS scale

Football 24M – 7 90.03821 46.0294 5.013F – 3 85.20352 46.5925 5.005

Rugby 35M – 4 79.10480 43.0132 5.990F – 3 75.92032 44.6938 5.012

Basketball 32M – 1 77.03843 43.6930 5.034F – 1 84.01929 44.5849 5.902

Greco-Roman wrestling 23 M – 2 87.29420 43.9028 5.011

The athletes remarked that during the last week of treatment they experienced almost no pain in those movements and physical activities which caused pain or discomfort earlier.


1716

3. Clinical Trials

Visual analogue scaleExamination 1 • Examination 2 • Examination 3

Fig. 1. Score distribution on the VAS scale according to the stage of the assessment.

The following Conclusions were made as a result of the study:The use of the B-Cure® Laser medical device in high-performance athletes leads to improved health indications in patients in the form of disappearance of the pain syndrome and discomfort in the affected joint. The final study demonstrates improvement of the support function of the affected limb, which leads to increased proprioceptive control and improved coordination.A course of physiotherapy which includes the use of the B-Cure® Laser medical device provides a reduction in the rehabilitation period for athletes with the symptoms of the knee joint osteoarthritis.No side effects when using the B-Cure® Laser device were identified.

ConclusionExpert effectiveness evaluation of the B-Cure® Laser physiotherapeutic device for high-performance athletes suffering osteoarthritis of the knee joint was carried out in this study. The study included:• Primary clinical evaluation (including the use of pain assessment scale) for high-performance athletes

with osteoarthritis of the knee joint.

• A 14-day physical therapy treatment using the B-Cure® Laser medical device excluding weekends (Saturday and Sunday).

• An evaluation, using pain assessment scales, of the orthopaedic status and functional status of the affected knee joint after the course of treatment with B-Cure® Laser was completed.

• The efficiency of the B-Cure® Laser medical device for athletes with osteoarthritis of the knee joint was confirmed and the final examination of this cohort of athletes was carried out.

The research objective was achieved. All specified tasks were completed. The conclusions corresponding to the results of the study were drawn, confirming high effectiveness of the B-Cure® Laser medical device for high-performing athletes with osteoarthritis of the knee joint.

Study Director I. V. Kruglova


Arnon D. Cohen, MD, MPH, PhD

Executive Summary:

• B-Cure® Laser LLLT808 (Good Energies, B-Cure® Laser & B-Cure® Laser Pro) is a powerful hand held soft-laser medical device, with a peak power of 250 mW at wavelength of 808 nm.

• In the following document we present evidence for the clinical use of the low level laser therapy the following diseases: carpal tunnel syndrome, fibromyalgia, myofascial pain syndromes (e.g. knee pain, low back pain, neck/upper back pain, muscle pain etc.), joint disorders (e.g. shoulder pain, arthritis, tennis elbow etc.), plantar fasciitis, and sports injuries.

• A literature review has demonstrated the beneficial effect of LLLT in high quality clinical studies in all the above mentioned indications.

• B-Cure® Laser & B-Cure® Laser Pro are approved by the Standards Institution of Israel and by the Israeli Ministry of Health.

• B-Cure® Laser & B-Cure® Laser Pro are being used in major hospitals and medical centers in Israel

• Several other LLLT devices with similar technical specification have a CE mark (Timelas Vital, Modulas Handy CW100, EKKy Lite and Power Laser 105) support the use of LLLT in the treatment of pain and inflammation.

• The current application of B-Cure® Laser & B-Cure® Laser Pro have superior power of 250mW as compared to lower power applied by the other CE approved devices cited above.

• Recent Studies conducted on B-Cure® Laser devices show: a) Significant reduction (50%) of pain levels experienced by patient suffering from TMJ/TMD conditions. b) Significant reduction of bacteria causing Gum inflammation and Periodontitis

According the literature review, the beneficial effect of LLLT has been demonstrated in high quality clinical studies, in all the above mentioned indications. The results of the literature review appear in Appendix 1.

Conclusions:The above mentioned literature review provide evidence base which indicates that B-Cure® Laser LLLT 808 treatment is clinically effective in the treatment of the following diseases: carpal tunnel syndrome, fibromyalgia, myofascial pain syndromes (e.g knee pain, low back pain, neck/upper back pain, muscle pain etc.), joint disorders/arthritis (e.g achilles tendinitis, tennis elbow etc.), medical skin conditions (e.g acne, vitiligo, herpes simplex, lymphedema, wound healing, fresh and old surgical wounds or scars, skin wounds, burns etc.), cosmetic skin conditions (e.g. post-pregnancy stretch marks (striae gravidarum), skin rejuvenation, wrinkles and skin aging, skin sensitivity, etc.), inflammation, hemorrhoids, headache, TMJ/TMD, Periodontitis and dental diseases.

3.6 Evaluation of Clinical Data - Low Level Laser therapy Device B-Cure LLLT808

3. Clinical Trials

1918

59%

41%

24%

76%

3. Clinical Trials

3.7 A cross-sectional post marketing survey to evaluate real-life customer experience and satisfaction after using the B-cure laser device


Background: Low level laser therapy (LLLT) is widely used for the treatment of a variety of inflammatory related conditions. The B-Cure laser is a home-use LLLT device that is sold in Europe and Asia for management of acute and chronic pain, as well as wound healing. To date, three small prospective double-blind randomized sham-controlled clinical trials were conducted with the device. Fornaini et al showed that daily self-treatment over the temporomandibular joint (TMJ) for 2 weeks significantly reduced pain typical to this disorder [1]. Moreover, in a separate study on the same indication, Del Vecchio et al showed that LLLT was comparable to the pain reducing effects of nonsteroidal anti-inflammatory drugs and both were superior to sham irradiation [2]. Adverse events related to the device were not reported in any of these studies. In view of these encouraging results from prospective controlled clinical trials, the company intended to evaluate the real-life experience and customer satisfaction with the device.

Methods: To that end, a phone survey was conducted by Geocartography Knowledge Group that specializes in customer surveys. The company was given a database of 10,000 coded numbers representing patients that purchased the device at least 3 months prior to the survey, with the intention to survey a sample of 300. After collecting demographic information, the customers were asked about the indication for which they used the device, the frequency of use and its timing, perception of the pain before and after using the device, satisfaction with the device, duration of pain relief, and side effects/adverse events.

Results and Discussion: 1) Accountability and response rate:

The survey includes answers of 300 customers. The response rate was 41%, which is considered exceptionally high suggesting that customers were interested in participating the survey.

2) Customer demographic characteristics: Two thirds (67%) of the customers that answered the survey were over 55 years old, which is 3 folds more than the percentage of this age group in the general population. The distribution by sex (56% males) was similar to the general population (49.5% males) (Israel central bureau of statistics, 2013). The customers were evenly distributed according to their income level.

3) Overall treatment effectivenessOverall, 138 of 300 (46%) of the customers reported that they were satisfied or very satisfied with the treatment. The %satisfied customers increased with the time of use, reaching 60% satisfied customers for those that had the device for a year of more (n=108) (Figure 1). The subjective pain reduction using the numerical rating scale (NRS) where 0 was “no pain” and 10 was “intolerable pain was 2.6±2.7 (mean±SD) and 3.0±2.5 respectively (Figure 2). Of the customers surveyed, 177 (59%) considered themselves as suffering intolerable pain (defined here as pain NRS=8-10). After treatment, 108 of these did not consider themselves in this category leaving only 24% in this category (p<0.0001 by chi square) (Figure 3).

Pie graphs by level of satisfaction for (left) entire survey population and (right) customers that used the device for 1 year or more. The proportion of satisfied or very satisfied customers was 46% and 60% respectively.

Figure 1: Customer satisfaction level

Very satisfiedSatisfiedSlightly satisfiedUnsatisfiedVery Unsatisfied

Figure 3: Proportion of customers with intolerable pain before vs after the treatment

Subjective pain level was reported using the numerical rating scale (NRS) where 0 was “no pain” and 10 was “intolerable pain for (left) entire survey population and (right) customers that used the device for 1 year or more. *p<0.0001 by paired t-test.

Intolerable pain is defined here as pain by numerical rate scale (NRS) = 8-10 and depicted in the graph in red part of the bar, while bearable pain is defined here as pain NRS ≤ 7. Note the significant decrease in the proportion of the customers that initially reported suffering from intolerable pain (59%) vs after using the device (24%). *P<0.0001 by chi square.

Post marketing survey for B-cure laser, Analysis by Dr. Lilach Gavish, PhD

Entire survey population

(n=300)

19%

21%

9%24%

27%

Used the device 1 year or more

(n=108)

26%

12%

9%19%

34%

60%46%

Before AfterTreatment

#Cus

tom

ers

in s

urve

y

Intolerable pain(Pain NRS = 8-10)

Bearable pain(Pain NRS 7)<_

0

50

150

100

200

250

300*

Figure 2: Subjective pain level before/after treatment

Before treatment

After treatment

Diffrerence (mean±SD)

Entire survey population

(n=300)

Used the device 1 year or more

(n=108)

Pain

leve

l by

NRS

Intolerable pain

No pain 0

2

6

4

8

10

* *2.6±2.7 3.0±2.5

2120



4) Treatment effectiveness by region:The major pain for which the customers reported using the device were knee pain (34%), low back pain (15%), and upper back and neck pain (11%). Using ANOVA adjusted for age, sex and initial pain level, it was demonstrated that there was no significant difference between the knees, lower back, upper back, or other regions regarding satisfaction level (p=0.69) or change in pain level (p=0.12).

It can be summarized that the treatment with B-cure laser results in effective pain relief in 46% of the customers and that this effect is similar in all regions and is unrelated to either age or sex.

5) Pain reliefCustomers that reported feeling pain relief up to 2 months after using the device also reported an average pain reduction of 3.0±2.8, 95%CI [2.4,3.5]. Of the customers that reported feeling pain relief, 43% experienced pain relief for at least 1 week after using the device and 25% reported several hours of relief. As expected, the level of satisfaction increased with the duration of pain relief.

6) Manner of treatmentMost customers (89%) used the device up to 15 minutes per session, of these, 24% used the device once a day, 46% twice a day, 23% three to four times a day, and 3% five to six times a day. As the number of uses per day increased, so did the percent of satisfied customers (38%, 46%, 47%, and 63% satisfied customers using the device for once, twice, 3-4 times, and 5-6 times a day). Superior effectivity was not found for a specific duration of treatment or frequency of use per period (p=0.9 and p=0.95 respectively by 1-way ANOVA for change in pain level). It can be summarized that increasing the number of treatments per day may increase the efficacy but in real life about half of the customers use the device up to 15 minutes twice a day.

7) Time of use and complianceA quantitative relationship between satisfaction levels and contributing factors was found as follow: The model was [satisfaction level] = a1*[how long ago was the device purchased] + a2*[when did you last use the device] + a3*[age] + additional factors [sex, frequency/duration of treatment, time of continuous use]. Using stepwise (backward) multiple regression the only contributing factors were the first three variables (coefficients, mean±SEM[p-value]: a1=0.35±0.06 [p<0.001]; a2=-0.22±0.03 [p<0.001]; a3=0.16±0.06 [p=0.005]). These three variables were uncorrelated (R<0.1 in all cases by

Spearman correlation coefficient). The model explained 75% of the variance. The interpretation is that higher compliance, represented by more frequent use (last use in a shorter time) and / or long-term use predicts higher satisfaction rates. Indeed, compliant customers that had the device for over a year and used it in the past 2 weeks (n=60) were significantly more satisfied than less compliant customers (73.3% vs 39.2%, p<0.001 by chi square of satisfaction level) and reported higher pain relief (3.7±2.4 vs 2.3±2.7, p=0.001 by 2-sample t-test). Analyzing the data by region it was found that compliant customers as defined here were much more satisfied for all regions than less compliant customers (%satisfied customers – lower back 100% vs 33%; upper back/neck 71% vs 53%; knees 53% vs 39%). It is important to note that customers that had the device for a year or more were similarly more satisfied and reported higher pain relief than those that had the device for less than a year although to a lesser extent than those that also reported using the device for the last 2 weeks (%satisfaction: 60.2% vs 37.3%, p=0.001 by chi square of satisfaction level; pain difference by NRS: 3.0±2.5 vs 2.3±2.8, p=0.053 by 2-sample t-test).

8) Side effects/adverse eventsWhen asked about the reasons to recommend the device, 80% related to the absence of side effects in addition to other reasons related to efficacy and ease of use. None of the customers reported experiencing adverse events.

ConclusionsThe characteristic customer is over age 55, both men and women, from all levels of income. Customers used the device for a variety of pain indications but the most popular regions were knees, lower back, and upper back/neck. Overall, 46% of the customers were satisfied with the device and reported pain relief that was not significantly different for the different regions of treatment, nor for sex or age. The % of satisfied customers increased with the length of use reaching 60% for the customers that used the device for a year or more. These customers were significantly more satisfied compared to those that used the device less than a year. Of the customers surveyed, 177 (59%) considered themselves as suffering intolerable pain (defined here as pain NRS=8-10), but after treatment, only 69 (24%) considered themselves in this category. Of the customers that reported feeling pain relief, 43% experienced pain relief for at least 1 week after using the device. In real life, about half the customers used the device up to 15 minutes twice a day although increasing the number of treatments per day increased the efficacy of the device. Finally, none of the customers reported experiencing side effects or adverse events.

References1. Fornaini, C., et al., The “at-home LLLT” in temporo-mandibular disorders pain control: a pilot study. Laser Ther, 2015. 24(1): p. 47-52.2. Del Vecchio, A., et al., Abstract: A new home protocol of LLLT in patients affected by TMJD related pain: results of a randomized, double blind, placebo controlled clinical trial, in The 15th Congress of the World Federation for Laser Dentistry. 2016: Nagoya, Japan.

Table 1: Effectiveness of treatment by pain level per region of treatment

Subset nNo.(%) of satisfied or

very satisfied customersPain before treatment*

Pain post treatment

Δ(before-after) pain, p-value**

Overall 300 138 (46%) 7.7 [7.5-7.9] 5.1 [4.8-5.4] 2.6 [2.3-2.9], p<.0001

Knees 101 42 (42%) 7.4 [7.1-7.7] 5.2 [4.6-5.8] 2.2 [1.7-2.7], p<.0001

Lower back 37 17 (46%) 7.9 [7.3-8.4] 5.1 [4.2-6.0] 2.8 [1.9-3.7], p<.0001

Upper back/neck 26 15 (58%) 8.1 [7.4-8.7] 4.5 [3.4-5.6] 3.6 [2.6-4.6], p<.0001

*mean[95%CI]; **by paired t-test

Case studies

2322

Roberta T. Chow, Mark I. Johnson, Rodrigo A. B. Lopes-Martins, Jan .M BjordalThe Lancet, 13/11/2009

Background:Neck pain is a common and costly condition for which pharmacological management has limited evidence of effi cacy and side-effects. Low-level laser therapy (LLLT) is a relatively uncommon, non-invasive treatment for neck pain, in which non-thermal laser irradiation is applied to sites of pain. We did a systematic review and metaanalysis of randomised controlled trials to assess the effi cacy of LLLT in neck pain.

Methods:We searched computerised databases comparing effi cacy of LLLT using any wavelength with placebo or with active control in acute or chronic neck pain. Eff ect size for the primary outcome, pain intensity, was defi ned as a pooled estimate of mean diff erence in change in mm on 100 mm visual analogue scale.

Findings:We identified 16 randomised controlled trials including a total of 820 patients. In acute neck pain, results of two trials showed a relative risk (RR) of 1·69 (95% CI 1·22–2·33) for pain improvement of LLLT versus placebo. Five trials of chronic neck pain reporting categorical data showed an RR for pain improvement of 4·05 (2·74–5·98) of LLLT. Patients in 11 trials reporting changes in visual analogue scale had pain intensity reduced by 19·86 mm (10·04–29·68). Seven trials provided follow-up data for 1–22 weeks after completion of treatment, with short-term pain relief persisting in the medium term with a reduction of 22·07 mm (17·42–26·72). Side-eff ects from LLLT were mild and not diff erent from those of placebo.

Interpretation:We show that LLLT reduces pain immediately after treatment in acute neck pain and up to 22 weeks after completion of treatment in patients with chronic neck pain.

3.8 Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials

3. Clinical Trials

Case Studies

2524

Case studyA 65 year old patient was diagnosed with a full tear of the right Supraspinatus tendon and a smaller central tear of the left Supraspinatus tendon. He reported pain particularly in the frontal section of his shoulders. He was treated with chiropractic adjustment once a week in the area of his neck, upper back, shoulder blades and shoulders. After the third chiropractic adjustment, B-Cure® Laser treatment was added, treating the sides and front of his shoulders for six minutes. The patient owned a B-Cure® Laser home device and was therefore instructed to carry out self treatment twice a day in these areas. After a week he reported improved range of motion and significantly reduced pain throughout his entire range of movement. On the other hand lying down at night the pain in his shoulders kept him awake. A week later at a follow up treatment he reported improvement while lying down. The patient postponed his decision to undergo surgery due to the vast improvement.

ResultsAfter a total of 6 weekly treatments in which six minute treatments with B-Cure® Laser were included in addition to 2-3 self treatments daily at home, there was a significant improvement in the range of painless movement in both shoulders, despite the existing tears in the shoulder tendons.

ConclusionsCombining B – Cure Laser in the treatment of chronic and acute tendon damage or even torn tendons, assists in reducing pain and inflammation and helps to make the surrounding tissue more flexible to enable broader, painless movement.

Dr. Ami Eyal Chiropractor and Kinesiologist

B-Cure® Laser treatment for rotator-cuff tear

4.1 Case studies - shoulder and upper back

Case study – Treatment with “B-Cure® Laser Sport Pro”

In this case study, the effectiveness of the B-Cure® Laser Sport Pro device was tested in the treatment of frozen shoulder. On December 9, 2014, a woman of 45 arrived at my clinic with pain and extremely limited movement of her left shoulder - sudden onset of Frozen Shoulder, resulting from unknown causes. The patient denied a history of trauma to the shoulder, and there is no report of an event that may explain the phenomenon. Her life partner was suffering from prostate cancer, a fact that caused much stress in her life, both psychologically and from the point of view of housekeeping tasks which she carried out while also running her own shoe store, and working in it full time. An examination showed a weakening of the shoulder muscles, the Rotator Cuff, and pain whenever she attempted to move her left shoulder joint. There is no limitation or pain involved in moving her left elbow or wrist, and there is no pain in neck motion though this was somewhat limited in range. Many Trigger Points were found in the Teres Minor muscles and the left Subscapular. Treatment included chiropractic adjustment to her left elbow, left shoulder and her neck in accordance with findings following the chiropractic examination. chiropractic examination. In addition the patient was given Dry Needling Acupuncture - intramuscular stimulation (IMS) to the Teres Minor muscle only during her first visit and to the left Subscapular only on her second visit. During all of her visits the patient’s left side of her neck and the connecting point of the trapezius muscle was treated with the B-Cure® Laser Sport Pro for one minute. On her first visit the patient was also treated with B-Cure® Laser Pro above the front section of her shoulder for one minute. On the second visit the back side of her shoulder was treated for one minute, and on the third visit she was treated at the connecting point of the proximal biceps. The entire treatment lasted from the 9th to the 18th December 2014 during which there were four treatments, all of which were carried out at the clinic. Following the treatments the patient was instructed to allow her shoulder to rest in a triangle sling, for the first three days, and to increase her liquid intake along with vitamin C as is consistent with IMS treatment. After the first visit there was a 75% improvement in the range of her left shoulder (successful Apley test) and a significant reduction in the level of pain, although external rotation was still painful and difficult to execute. After the fourth visit the patient reported a 100% improvement in the range of movement and 95-99% improvement in pain level.The results show the efficacy of treatment with the B-Cure® Laser Pro for patients with frozen shoulder, particularly in combinations with chiropractics and Dry Needling (IMS).All questions or remarks may be sent to Dr, Hirsh at [email protected]

Sincerely,Dr. Omer Hirsh DCChiropractic and Functional Neurology

4.1 Case studies - shoulder and upper back

B-Cure® Laser treatment for frozen shoulder syndrome

2726

B-Cure® Laser treatment for ischias and disc problems

4.2 Case studies - lower back

3/11/2014 CASE STUDY with B-Cure® Laser Sport Pro

The Patient: A 60 year old athlete who rides a bike daily, for an average of 40 km. a day.

Case description:The patient suffers from lower back pain and difficulty using the Abductor tendons The pain increases during cycling and hurts more upon his return.

Prognosis:Dynamic pain; the cause is lumbar pressure from an L4-L5 prolapsed disc radiating to the sciatica and asymmetrical posture, cartilage erosion of the (femora) hip joint.

Series of 12 treatments:The patient underwent a series of treatments including: osteopathic treatment, Acupuncture combined with B-Cure® Laser Sport Pro treatment. During the first 6 appointments there was no change in the pain or the range of movement.Intensive treatment was introduced from the 7 th appointment using the device twice a day for 8 minutes at two focal points (the hip joint and the lower back).

Results:Pain decreased after using the device for an additional two weeks, to the point of negligible pain and no limitation of the range of movement.

My professional recommendation:I recommend using the B-Cure® Laser Sport Pro for sports injuries and pathology such as prolapsed disc, inflamed sciatic nerve etc.

Sincerely,Dr. Yossy Ruven N.D / D.O




The Patient: Combatant soldier aged 19

Case description:Erector Spinae inflammation, as a result of long term carrying of heavy weights.Diagnosed as suffering from acute longissimus myalgia. Suspected Polymyositis.

Prognosis:Has been suffering for about a month. Pain in various situations including standing, sitting, lying down and walking.

3 week treatment:The patient underwent osteopathic treatment as well as the use of B-Cure® Laser Sport Pro twice a day for two weeks at the clinic.

Results:By treatment no. 6 there were changes in the level of pain. By treatment no. 7 I stopped the osteopathic treatment and the soldier continued using the device at home for an additional week, twice a day for 8 minutes at the point of treatment.After this period the soldier reported that the pain had ceased in the areas he had complained about.

Professional recommendation:In light of the results I recommend the use of the B-Cure Sport Pro device for orthopedic problems as above, and suggest examining the possibility of introducing the device into military clinics.


2928




The Patient: a 64 year old woman.

Case description:The patient suffers lower back pain radiating to her left hip, when standing and standing up from seated position.

Diagnosis:Femoral Arthritis, L3-L4 prolapsed disc S1-L5- prolapsed disc with directional changes

Prognosis:Examination of the femoral hip joint showed limitation of movement, sensitivity and pain radiating to the groin. Limited circumferential movement of the hip , Possible Femoro Acetabulas IngingementWas previously treated by a physiotherapist at the HMO clinic, with ultrasound and electrodes once a week with no improvement.

3 weeks of treatment:The patient was treated at my clinic “The Israeli Center of Natural Therapy” and was given osteopathic treatment in conjunction with Acupuncture and ultrasound for 1 week with no significant improvement. Results:After 10 visits I instructed the patient to add treatment with the B-Cure® Laser Sports Pro for an additional ten days. After ten days significant improvement was achieved and complete elimination of the pain.

My professional recommendation:In cases of inflamed joints, also involving the lower back, I recommend using the B-Cure® Laser Sport Pro to facilitate and expedite the process of recovery.


Patient:55 year-old male project manager in good health that sits 6-8 hours per day in front of the computer.

Problem:Came to see me in November 2014 after having undergone lumbar spine surgery at levels L4-L5 six months earlier. The disc at this level had ruptured and part of it had broken off, compressing the nerve roots on the right side which resulted in excruciating pain locally with pain radiation down the right buttock and leg. Surgery helped his condition for six months but the pain returned and left the patient bedridden for three days before he could come to my office for treatment.

Prognosis:Initially the patient tried pain medication with temporary relief only. After 12 chiropractic treatments in my office, patient was off pain medication and improved his condition by 70 percent.

Treatment protocol at my clinic:The patient began to use the B-Cure® Laser Sport at home for a total of eight days in February 2015 along with continued chiropractic treatment one time per week. He applied the laser three times per day at the L4-L5 level on 3 treatment areas and on the right buttock directly on the painful area. Treatment time was 1.5 minutes on each area on day one, and increasing the treatment time by one minute each day to a maximum of 8 minutes per treatment area.

Results:With the addition of the B-Cure® Laser Sport, he noticed improvement with the low back and buttock pain after day three, and reported continued improvement after eight days of use. He says he feels 90 percent better but he can still feel back pain when he rotates his back to the right. He was able to return to his normal activities with only minor discomfort.

Professional Recommendation:For post surgical lumbar spine pain I recommend using the B-Cure® Laser Sport on a regular basis to all professionals treating these types of cases.

Dr. Jacob Hans, D.C., BSc.U.S.A. Board Certified Chiropractor

B-Cure® Laser treatment for lower back, rehabilitation post surgery

20/2/2015


3130

Patient:73 year-old retired diabetic male. Usually very active who takes some medication for diabetes.

Problem:Came to see me due to an injury to his lower back that he sustained a week previously after lifting heavy luggage while traveling. The pain radiated to his right buttock and to the side of his right leg. The pain was strong enough that he could not walk normally and had to stop his usual exercise routine. He also complained of a left shoulder pain that had never resolved since 2012 after lifting a heavy box.

Prognosis:Received only 2 chiropractic treatments for the back pain abroad with good results before he returned to Israel. The pain returned after a few days and was the reason he came to see me.

Treatment protocol at my clinic:Patient started care in January 2015. After two chiropractic treatments there was some improvement with the back pain but not with the shoulder problem. He began to use the B-Cure® Laser Sport at home along with continued chiropractic treatments two times per week. On the first day, he applied the laser two times per day on his lower back and right buttock and to his left shoulder, for 6 minutes on each treatment area - 3 for the low back, 1 on the right buttock directly on the painful area, and 3 for his shoulder. On day two and afterwards the treatment time was 8 minutes per treatment area, for a total of eight days.

Results:With the addition of the B-Cure® Laser Sport, he noticed an immediate improvement with the low back and buttock pain and reported that he felt 80 percent better after eight days. He was able to return to his normal activities with only minor discomfort. The shoulder pain also improved within this period, but more slowly.

Professional Recommendation:For low back and shoulder problems I recommend using the B-Cure® Laser Sport on a regular basis to all professionals treating these types of cases.


B-Cure® Laser treatment for Shoulder and lower back pain


Case studyA 19 year old girl following a year of limited movement in her left elbow, fixed with a sling at 160 degrees resulting from a fall. Movement is accompanied by grinding sounds and sensitivity throughout the range of movement. The area was treated a year and a half earlier and has not improved. The patient was given chiropractic treatment. From the first treatment it was decided to include treatment with the B-Cure® Laser device. It was used to treat the ventrolateral section for 6 minutes. A week later the treatment was repeated a second time and the patient reported significant improvement in the range of movement, so an additional laser treatment was added in conjunction with the previous treatment protocol. Today, a month and a half later, the improvement achieved in just two treatments, has been maintained.

ResultsComplete recovery of the full range of movement, and reduced sensitivity to pain.

ConclusionsIntegrating B-Cure® Laser Sport in the clinic for the treatment of old trauma that had caused contration of tendons, muscles and ligaments may be advantageous and offer significant efficacy in shortening the length of treatment.


B-Cure® Laser treatment for injured elbow

4.3 Case studies - elbow

3332

Case study – Treatment with “B-Cure® Laser Sport Pro”

In this case study, the effectiveness of the B-Cure® Laser Sport Pro device was tested in the treatment of wrist pain. On December 11, 2014, a woman of 35 arrived at my clinic complaining of pain in her left wrist for a number of days. The Patient denies a history of trauma to her hand, but mentioned that she was a mother of three, the youngest of which was 10 months old, who she carries much of the time. In addition she has a part time job at a kindergarten, lifting children many times during the day. I believe that is the main cause of the pain. Upon examination by touch the wrist was found to be sensitive in front of and behind the Scaphoid bone, as well as there being sensitivitiy and slight weakness at the trigger points of the Flexor Carpi Radialis muscle.

Treatment included chiropractic adjustment of the left wrist, the elbow and the neck based on the findings of a chiropractic examination. This adjustment was carried out only during the first visit. The patient was also given Dry Needling (IMS) in the Flexor Carpi Radialis muscle. Treatments lasted about two weeks and ended on December 26, 2014. During this time the patient had only five treatments and during all of these visits, the patient’s wrist was treated with B-Cure® Laser Sport Pro. The patient was treated on the Posterior aspect of the wrist during the first three visits, and the Anterior aspect during the last two visits. The laser was focused on the painful area, above the scaphoid bone, for one minute for each treatment over two weeks, during which she was also given chiropractic adjustment and IMS during the first visit, and five treatments with B-Cure® Laser Sports Pro at the clinic. In addition the patient was instructed to avoid movements that aggravated the pain, to drink a lot of water and to use Vitamin C as is the common practice for IMS treatment.After the second visit the patient reported an 80% improvement and after five treatments she reported complete disappearance of all symptoms. The results show the efficacy of treatment with B-Cure® Laser Pro for patients with wrist pain, particularly in combinations with chiropractics and Dry Needling (IMS).All questions or remarks may be sent to Dr, Hirsh at [email protected]


B-Cure® Laser treatment for pain in the wrist

4.4 Case studies - palm and hand

Patient:69 year-old female art therapy teacher in generally good health.

Problem:Had been suffering with very strong pains in her right hand for three months before she came to see me. Her hand also went numb a few minutes after driving as well as at bedtime. Nine years previously she had very traumatic Carpal Tunnel Syndrome (CTS) surgery of her left hand. Recent EMG confirmed CTS of her right hand with median nerve damage. Patient was very nervous about having another surgery and wants to avoid it at all costs.

Prognosis:Tried acupuncture for more than 12 visits without any change in her condition before coming to see me.

Treatment protocol at my clinic:Patient came to see me in January 2015. After three chiropractic treatments, there was no change in her condition. She began to use the B-Cure® Laser Sport at home along with continued chiropractic treatments two times per week. She applied the laser two times per day on her right hand and wrist as well as on her neck, for 1.5 minutes on each treatment area - 3 for the hand and wrist and 3 for the neck. Each day, for a total of eight days, she increased the treatment time by 1 minute to a maximum of 6 minutes per treatment area.

Results:After using the B-Cure® Laser Sport for three days she reported that the pain had decreased, however the numbness still persisted. On day four, for the first time in three months, the numbness had cleared at night, which allowed her to sleep better for two nights. On day eight she reported continued pain relief and although she still experiences some tingling and numbness while driving and some at nighttime, it is much less and continues to improve.

Professional Recommendation:For hand problems, including Carpal Tunnel Syndrome (CTS) I recommend using the B-Cure® Laser Sport on a regular basis to all professionals treating these types of cases.


3/2/2015

B-Cure® Laser treatment of carpal tunnel syndrome


3534

Case studyA 33 year old patient whose job is computer programming, complained he had been suffering from chronic pain in the base of his right thumb, for the past year and a half. Examination showed sensitivity and pain to the touch throughout his hand. As a result of the limitations of his right hand, the left hand activity had been increased, thus causing pain to the left hand and fingers, particularly the middle finger. He was given chiropractic treatment to the neck and upper back and electro-stimulation to the tendons and muscles of his arms and the carpel joints and the base of his thumbs. He was given a number of treatments after a number of treatments with B-Cure® Laser at the base of his thumb in addition to the other treatments, once for five minutes on both hands at the end of the treatment. A week later the patient was treated with B-Cure® Laser in the area of the Carpal tunnels of both hands, (for six minutes). A week later another treatment was given to the thumb base.At this stage there was an improvement to both thumbs and hands, but his third finger of the left hand was still painful, so that additional therapy was set for the dorsal section of the hand between finger 2 and 3 in additional to the chiropractic treatment. After two treatments to the third finger of the left hand, integrating the B-Cure® Laser, significant reduction of pain was achieved. After three additional treatments of the tendons that straighten and stretch the third finger, permanent improvement of the pain in the finger was achieved. The improvement in hands, fingers and carpel joints has been maintained.

ResultsGradual improvement with significant and measurable changes was noted after each weekly treatment; there was significant reduction in pain despite the patient’s carrying on working as usual.

ConclusionsIntegrating treatment with B-Cure® Laser Sport Pro in the clinic in situations of pain and inflammation of the tendons and muscles in the hands and fingers, and in situations of C.T.S increases the efficacy of the cure and shorten recovery times.


B-Cure® Laser treatment for carpal tunnel syndrome (CTS)


B-Cure® Laser treatment for hand contusion

Patient: My 6 year-old healthy son.

Problem: My son was playing under a table at school when the table tipped over and crushed his left hand. He was taken to emergency clinic where he was x-rayed, bandaged, and was diagnosed with Contusion of his left hand. When I first saw him there was significant swelling of the middle and index fingers at the metacarpal-phalangeal junction on the dorsal aspect of his left hand, and an open wound on the palmar aspect where the table had made contact. He was in pain, and could not move his fingers.

Prognosis: He had ice pack placed on the injury immediately at school and had it on and off for 40 minutes before he was taken to the emergency clinic to be treated.

Treatment protocol at my clinic: I saw him three hours after the injury occurred and started treatment immediately with the B-Cure® Laser Sport. I treated three areas on the dorsal aspect of his hand and one area on the palmar aspect just inferior to the open wound, but not directly on it. Treatment time was 6 minutes per area with a 5 minute break between the first two sessions. Four hours later he received another two sessions. On the first day he received four treatments lasting 24 minutes each session, as well as on day two and day three. Thereafter he received 24 minute treatments two times per day for seven days.

Results: After the second session on the first day he said that the pain was going away but he could still not move his fingers. By the end of the second day, after eight sessions, he could move his fingers due to reduction of pain. On day four he was moving his fingers freely and playing catch with his friends, without a bandage, although some swelling was still present at the site of injury. On day seven he was able grasp objects normally and put weight directly on his hand with no discomfort. The swelling resolved after ten days.

Professional Recommendation: In the past, for this type of injury I would ice the area for much longer and use homeopathic Arnica gel to speed up the healing. However, in this case, I decided to only use the B-Cure® Laser Sport as the only therapy. I was shocked at how fast it worked, not only to relive the pain, but to actually heal the injury! Although the swelling persisted for ten days, its effect on pain reduction and improved function convinced me that the B-Cure® Laser Sport is a professional tool that every doctor should have in their clinic. Dr. Jacob Hans, D.C., BSc.U.S.A. Board Certified Chiropractor

5/3/15


3736

Patient:56 year-old female secretary. Takes medication for high blood pressure but otherwise in good health.

Problem:Right hip and groin pain for five years that has been getting worse. X-rays were normal. There was point tenderness on the right groin, and hip and groin pain with internal hip rotation. She complained the groin pain woke her up at night and was not sleeping well because of it. The pain also came after 10 minutes of walking, especially going up or downhill, which prevented her from going hiking.

Prognosis:Patient tried pain medication for several months with limited results.

Treatment protocol at my clinic:Patient started care in February 2015. After seven chiropractic treatments, there was some improvement with the hip pain during walking, but no change with the groin pain at nighttime. She began to use the B-Cure® Laser Sport at home along with continued chiropractic treatments two times per week. On the first day, she applied the laser two times per day on her right hip on three treatment areas and on her groin in one area for 1.5 minutes per treatment area. She increased the treatment time by one minute each day to a maximum of 8 minutes per treatment area for twelve days.

Results:After using the B-Cure® Laser Sport for five days she reported she was sleeping much better at night with less pain. By day twelve she was sleeping through the night without any groin pain. She is also able to walk for longer distances before she needs to rest due to hip discomfort. Although she still has some hip pain while walking, she is very happy that she can now sleep through the night.

Professional Recommendation:For hip and groin problems I recommend using the B-Cure® Laser Sport on a regular basis to all professionals treating these types of cases.


B-Cure® Laser treatment for hip pain

17/3/15

4.5 Case studies - hip and groin

B-Cure® Laser treatment for hip condition

4.5 Case studies - hip and groin


The Patient: a 54 year old woman.

Case description:Suffers from pain in the hip joint and limited movement as a result of prolonged standing. Prognosis:Femoral cyst in the right hip joint, evident subchondral edema, narrowing of the femur and joint fluid, possible tear in the b labrum tendon in addition to possible right hamstring tendon inflammation.

12 Treatments once a week:The first treatment was on November 12, 2014 during which the patient received osteopathic treatment combined with B-Cure® Laser Sport Pro treatment. 3 weeks later the patient continued self administration at home with the device only – twice a day for 6-7 minutes. for an additional two weeks. Results:A month and ten days later, the patient has gone back to doing all routine activities including prolonged standing without pain.

My professional recommendation:I recommend using the B-Cure® Laser Sport Pro in pathology that includes inflammation, cysts, limited movement with guidance to avoid unnecessary surgery.


3938

B-Cure® Laser treatment for severe knee pain

4.6 Case studies - knees

Case study – Treatment with “B-Cure® Laser Sport Pro”Combined treatment with B-Cure® Laser Sport Pro and B-Cure® Laser home device. A case which examined the efficacy of B-Cure® Laser Sport Pro in the treatment of knee pain

On January 29, 2015, a woman of 64 arrived at my clinic with pain in both knees, a little worse on the left than the right and limited range movement of the joint. She experienced limitation in daily activities such as going up and down stairs (needed to place both feet on each step) and walking. The patient reported a history of Wallenberg Syndrome, a stroke in the lateral brain stem (“Lateral Medullary Syndrome”) on the right side. This syndrome affects the right side of the body and the left side of the face. According to her report, the knee pain has existed for many years. The patient is significantly overweight, and since there are 14 steps in her home between the downstairs and her bedroom, her knee pain is a serious cause of a serious problem in her life. The examination showed a weakness of the Rectus Femoris muscle on the left and pain in the front and back of her knee, weakness in the extensor muscles, the four Quadriceps muscles on the left and a pain pattern resembling Rectus Femoris, weakness of the Hamstrings on the left with partial pain at the back of the knee in particular and weakness of the Psoas on the left without pain. Trigger points were discovered upon touching the Quadriceps muscles, sensitivity in the tendons of the medial hamstring. Examination showed findings in the right knee as well as neurological findings neurological findings; treatment was directed to the left knee. Treatment involved chiropractic adjustment to the left knee and the pelvis according to the relevant findings of the chiropractic examination. In addition, the patient was given Dry Needling (IMA) in the centre of the Quadriceps during this visit, as well as treatment with the B-Cure® Laser Sport Pro to the lateral area of the left knee joint, the top of the joint and the medial part of the joint, each for one minute. Later the patient was given instructions to use the B-Cure® Laser Sport Pro at home for three consecutive days, three times a day as per the treatment given in the clinic. Including the clinic treatment, the patient was given nine treatments over three days, and in addition she was given instructions to increase the intake of liquids and vitamin C as is accepted practice for Dry Needling.On February 1, 2015 the patient arrived for a follow up. She was again given treatment with the B-Cure® Laser Sport Pro device, at the same points, as well as treatment to the head of the left Fibular Proximal, and Dry Needling of the Vastum Medialis Obliques (VMO) muscle. The patient continued treatment at home with the B-Cure® Laser home device, not with the Sport Pro model. She continued treatment of all points with the home device including the fibular, for two minutes. After this visit the patient left the clinic climbing the stairs at the clinic without support, one foot at a time. On February 6, 2015 the patient came for another check up. She reported new pain in the area of the left Gastrocnemius muscle. After questioning it became clear that she had been ascending and descending the stairs at least seven times per day during the past week! There was an improvement of over 50% in her mobility compared to how she had been before treatment commenced. The patient continues to use the home B-Cure® Laser device, and visits the clinic for treatment with the B – Cure Laser Sport Pro. Due to the chronic status of her lack of balance and knee pain as a result of the stroke, the likelihood of a complete recover from pain is low though not impossible. The results indicate the efficacy of the use of B-Cure® Laser Sport Pro in treating chronic knee pain with or without the complication of the circumstances of the other syndromes, particularly in combination with chiropractic treatment and IMS. It appears that in these cases, the additional use of the home B-Cure® Laser home device also contributes to the treatment.All questions or remarks may be sent to Dr, Hirsh at [email protected]


B-Cure® Laser treatment for knee osteoarthritis


1/01/2015CASE STUDY with B-Cure® Laser Sport Pro (32)

The Patient: 41 year old married man, father of three with a job that entails active physical work.

Case Description:Suffering from joint pain.Pain and swollen knees, possible accumulation of fluids with localized heat and limited movementPossible Osteoarthritis and rheumatoid arthritis.Has been suffering from this for five years, has not been treated and is taking no medication.

Prognosis:Cooling the area with ice, Acupuncture one a weekcombined with B-Cure® Laser Sport Pro treatment.

Treatment for 3 weeks:The first treatment was in November 2014. Treatment lasted 1 minute and a half with B-Cure® Laser Pro, during the first meeting during the first meeting, and was combined with Acupuncture.Following this the treatment with the device was for 7-8 minutes at each point of treatment.The patient continued to use the device, self administering for 3 weeks, twice a day at home.

Results:3 weeks after the first treatment the pain stopped, the swelling subsided; there was no accumulation of liquid in the joints and no limitation of movement.

My professional recommendation:I recommend using B-Cure® Laser Pro for acute problems of the joints.


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B-Cure® Laser treatment for knee injury

October 14, 2014

Case description - Integrating B-Cure® Laser in the process of rehabilitation of Olympic athletes

“An Olympic gymnast aged 17 hurt her knee coming off the beam. She was diagnosed with a tear to the Anterior Cruciate Ligament, and she underwent surgery to restore the ligament. She then went through the process of rehabilitation at Wingate Institute in the department of sports injuries, based on the latest protocol for restoring complete range of movement, stability and muscle control, advancing to functionality according to the recovery schedule. During rehabilitation posterior knee pain appeared which did not improve under the usual treatments (soft tissue massage, mobilization, heat/cold, ultrasound etc.)

After a number of weeks of continuous pain which did not allow for full functionality, the B-Cure® Laser Sport treatment was added and the athlete was given instructions to use the device 2-3 times daily, on the 3 points that were chosen, each for 4-8 minutes, in addition to the ongoing treatment she had been getting till then. A week later the athlete reported a clear improvement, and the pain behind her knee had almost entirely disappeared. The athlete was requested to continue treatment with the B-Cure® Laser Sport for an addition three weeks, twice a day. Approximately two months from the first treatment, the athlete reported that she no longer suffered any pain and she is at this time back to full activity”.

Dr. Luba GalizkayaHead of Sports Medicine Wingate Institute.

Patient:Very active 70 year. old female Hebrew teacher. Takes medication for high blood pressure.

Problem: Right knee pain for seven years. There was some swelling of the knee upon visual inspection and tenderness upon palpation. Her orthopedist recommended knee surgery due to degeneration of cartilage and decreased joint space. Because her work requires that she walk long distances to her student’s homes every day, she is tired of suffering but does not want to have surgery.

Prognosis:Patient tried pain medication, had special orthotics made and had cortisone shots. These approaches helped temporarily but the knee pain kept coming back.

Treatment protocol at my clinic:After our initial consultation in February 2015, the patient requested postponing chiropractic care at a later time and insisted in first using the B- cure Laser Sport for her knee pain. I agreed and prescribed home laser treatment. She applied the laser two times per day on her right knee for 1.5 minutes on each treatment area which included a total of 4 areas. Each day, for a total of eight days, she increased the treatment time by 2 minutes to a maximum of 8 minutes per treatment area.

Results:After using the B-Cure® Laser Sport for four days she reported some pain relief, but was still difficult to walk due to the pain. On day eight she said she noticed significant pain reduction and could walk longer distances before the pain began. She is convinced that treatment with the B-Cure® Laser Sport helped her more than anything else that she has tried and would purchase a laser for continued home treatment.

Professional Recommendation:For knee problems I recommend using the B-Cure® Laser Sport on a regular basis to all professionals treating these types of cases.


B-Cure® Laser treatment for knee pain

11/2/15


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Case studyA 29 year old basket ball player presented with pain in the left Achilles tendon after falling on this leg in a game. In addition to Chiropractic adjustment of the pelvis, trigger points were activated in the area of the tendon and the left calf, and this was combined with B-Cure® Laser treatment of the tendon itself for about 5 minutes.

ResultsThe patient reported significant relief from pain in the tendon after one treatment. We continued treatment three times, once a week (he was unable to come more often) and he reported complete recovery with no pain in the tendon and the ankle during training.

ConclusionsCombining B-Cure® Laser treatment for injuries of strained tendons and ligaments and sprains is highly effective in healing the area of the injury and in granting fast relief from pain.


B-Cure® Laser treatment for Achilles injury

4.7 Case studies - feet

Case StudyAn 18 year old professional dancer came to me with pain in the left side of her groin and her left lateral foot. She was given chiropractic treatment to balance the pelvis and lumbar treatment for her left foot.After two weeks there was an improvement in the left side of her groin but not in her lateral foot.At this point we added treatment with B-Cure® Laser to the painful area of her foot in addition to the existing treatment, once at every visit, for 6 minutes. After two visits a week apart, there was complete recovery from the pain in her foot.After a month of further routine dance training with no treatment to the area, the pain came back in the same place. The combined treatments were therefore renewed using the B-Cure® Laser and once again complete recovery was achieved in two visits, two weeks apart. Routine training was renewed and there were no further complaints reported.

The results:Very fast improvement to her foot pain, in all ranges of movement and putting full load on it during dancing.

Conclusions:Integrating the use of the B-Cure® Laser Sport in the clinic for cases of Sprain and Strain injuries increases the efficacy of treatment, shortens recovery time and allows a quick return to the routine athletic training.


B-Cure® Laser treatment for foot injury


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B-Cure® Laser treatment for repeating ankle and for plantar faciitis

October 14, 2014

Case description - Integrating B-Cure® Laser in the process of rehabilitation of Olympic athletes

An Olympic athlete – a Judoka aged 23, was suffering from repeated sprains in both ankles. He had previously been diagnosed with a syndesmosis sprain (compound sprain) in his left ankle. It should be mentioned that he had been suffering pain and limited functionality during the past few weeks, after every jolt or blow. Treatment for the last sprain to his ankle had begun with routine physiotherapy but in this incidence we also introduced immediate treatment with B-Cure® Laser to the area of the injury. The athlete used the device twice daily for ten days. His reaction to the treatment was significantly more rapid than his recovery from the previous injuries he had experienced. Accordingly the athlete was back at his full capacity within two weeks of the last significant sprain. An Olympic athlete of 23 (triple jump) underwent surgery on her top foot to fix a tear in her fascia planter. It is a complicated procedure performed by the athletic foot specialist attending the International World Athletes Association. During post op treatment B-Cure® Laser was immediately used to reduce swelling. The athlete reported immediate benefit from the treatment, including reduced pain and decreased need for pain killers. This was significant in commencing the process of movement and active rehabilitation as early as possible. The athlete was back in training and competitions according to the schedule set by the surgeon. To sum it up, these cases demonstrate the advantage of using the B –Cure Laser treatment in a variety of diagnosis and injuries of athletes. The simple self administration is safe and expedites recovery time, reduction of pain and early as possible return to fully functional activities.

Dr. Luba GalizkayaHead of Sports Medicine Wingate Institute.

B-Cure® Laser treatment for hallux valgus and heal spur



The Patient: Aged 82, generally active and healthy. Takes medication for high blood pressure and Diabetes.

Case description:Acute big toe joint pain – Hallux Valgus red and sensitive.Also localized pain in the Calcaneus (heal bone), apparently a spur.

Prognosis:Has had 12 physiotherapy treatments at his HMO clinic with no apparent change.

Series of 12 treatments:He was treated at my clinic in October 2014, with Acupuncture and physiotherapeutic ultrasound, along with local cooling with ice. During the second visit I also used the B-Cure® Laser Sport Pro device for one and a half minutes (short treatment to examine the reaction).Following that the patient continued self administration on a daily basis with the device at home without any other types of treatment, 3 times a day for 7 minutes each time.

Results:4 days into his self treatment at home, the pain in his ankle was significantly reduced. After 10 additional days it was completely gone, and the pain in the Hallux Valgus was reduced from level 8 to level 2.

My professional recommendation:I recommend using the B-Cure® Laser Sport Pro as an efficient and vital device at all stages of inflamed joints and Hallux Valgus as well as for treating spurs.


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B-Cure® Laser treatment for hard healing wounds and edema

4.8 Case studies - wounds and skin problems

Case Study using B-Cure® Laser Pro

Anamnestic case history:A 78 year old woman with severe heart failure, and elephantiasis presenting with lymph blister leakage due to lymphostasis.

The course of treatment:Each lesion was treated for 4 minutes once a day for a month and a half.Conventional treatment, brought about no relief for a long time until treatment was combined with the B-Cure® Laser treatment, 4 minutes per area.Treatment was given in conjunction with the antibiotic cream which had previously given no relief but once integrated with the B-Cure Lazer treatment, there was a significant improvement.

Clinical findings:After the start of this treatment, there was a significant improvement in the wounds, and only a few are left and they are healing.

Conclusion:Improvement of lesions and lymph leakage.

Professional conclusion:I recommend the use of B-Cure® Laser Pro, as supporting treatment in conjunction with “conventional” medicine for treatment of lesions in the geriatric population.

Medical Manager Dr. Ze’ev FidelmanSpecialist in Internal Medicine and Geriatrics, Professor Emeritus


Anamnestic case history:An 80 year old man suffering from cardiac failure and edema in the legs.The patient has superficial wounds on both calves, with secondary infection, a consequence of edema.

The course of treatment:Treated for a week with the B-Cure® Laser device, 3 minutes on each lesion, twice a day. Also treated with antibiotic cream.

Now:A significant improvement, there remain a number of superficial lesions, swelling in the legs decreased.

Results:The lesions are closed.

Professional conclusion:I hereby recommend the combination therapy of the B-Cure® Laser device with conventional local treatment for lesions that are difficult to heal as presented by the geriatric population.




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B-Cure® Laser treatment fordiabetic lesions



Anamnestic case history:A man of 82, suffering from diabetes, accompanied by severe neuropathy; a handicapped amputee.Multiple diabetic lesions, difficulty healing. Due to diabetic neuropathy and due to severe ischemia his right foot was amputated.

Process of treatment:For a month, four minutes of treatment for each of the focal points in combination with conventional treatment.

Results:After a month there was a significant improvement and the process of healing began. The lesions looked cleaner and less complex. There is a definite reduction in the pain level from level VAS 9 to level VAS 2.

Professional conclusion:In light of these findings I can recommend the use of B-Cure® Laser Pro, as a supporting treatment device in conjunction with “conventional” medicine.


B-Cure® Laser treatment for hard healing wounds



The Patient:A 93 year old woman with age-related decreased functionality without known significant medical history, for research, showing no edema in the legs; Skin peeling, a skin tear wound on the calf

Course of treatment:The wound was treated for 5 minutes; Since local treatment had been unsuccessful, we introduced the B-Cure® Laser treatment device and there was then a significant gradual improvementTreatment began on 16:01:15 and ended 13.03.15 Total treatment time - 56 days

Result:Visible progress can be seen in the photos of the wounds - after several days with the beginning of a scab, showing that the healing process was reasonable. It should be noted however, that during the treatment a secondary infection appeared slowing down the pace of the process of healing. Taking into consideration the slow blood flow in a geriatric patient, we witnessed the healing process without added medication, other than a sterile dressing to the wound.

Professional conclusion:I hereby recommend using the B-Cure® Laser device in combination with conventional treatment for wound healing problems that present in the geriatric population.


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Anamnestic case history:101-year-old woman suffering from chronic heart failure, edema in the legs, skin peeling on her calves with secondary infection.

Course of treatment:5 minute treatments per lesion, one wound was left untreated as a control for study. Photos were taken.

Duration of treatment:One MonthYou can clearly see the fast healing and the emergence of more connective tissue in the early stages.

Result:Photos indicate the benefit to the wounds and the appearance of scabbing only after a number of days.

Professional conclusion:I recommend using the B-Cure® Laser device for the treatment of difficult to heal geriatric sores in conjunction with conventional medication.


Photo before treatment (one of the three wounds)

Photo after a week of treatment

Photo after 30 days treatment

B-Cure® Laser treatment for hard healing wounds



Anamnestic case history:A 91 year old woman functioning poorly; a cardiac patient who had been presenting severe leg wounds for more than six months, multiple superficial wounds on both thighs.

The course of treatment:The resident was treated once a day, for about 2 minutes per wound for three months.

Professional conclusion:Although the rate of progress of the healing was slow, it should be emphasized that this was due to the vascular problems stated.From the beginning of the treatment the healing process was quite fast, considering that the above-mentioned sores began last July.Now all that is left of these chronic wounds is a dry scab.


Photos before treatment

Photo after 2 days treatment Photo after 3 month treatment

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B-Cure® Laser treatment for neuropathic pain



Anamnestic case history:A man of 82, an amputee suffering from diabetes, accompanied by severe neuropathy;

Complaint:Pain in the area of the amputation VAS-7

Process of treatment:For a month, four minutes of treatment for each of the focal points in combination with conventional treatment.

Results:After a week improvement - reduction of pain level from VAS 7 to VAS 1.

Professional conclusion:In light of these findings I can recommend the use of B-Cure® Laser Pro, as a supporting treatment device in conjunction with “conventional” medicine for pain relief.


Date: 06.11.2009Dr. Avi Reyhanian,Private Clinic ,Netanya, Israel1 Shaar Haemek St. Netanya 42292, IsraelOffice: +972-9-8338825Fax: +972-9-8339890E-mail: [email protected]

C.VDr. Reyhanian graduated from the University of Bucharest, Romania in 1988. He then participated in a fellowship program at the Oral & Maxillofacial Department at Rambam hospital in Israel. He is a member of the academic staff at the Institute of Advanced Dental Education in Haifa, Israel and he currently practices general dentistry and oral surgery in Netanya, Israel.Dr. Reyhanian’s practice has employed dental lasers since early 2002. He is a member of the ALD –Academy of laser dentistry- and is a member of the Israel Society of Dental Implantology. Four wavelengths are used in his practice: Erbium: YAG (2940nm), CO2 (10600nm) Diode (830nm) and LLLT-Good Energies-(808nm).Dr.Reyhanian has been publishing and lecturing extensively worldwide in the field of dental laser. His reviews appear in several dental journals. Dr.Reyhanian was the global opinion leader of Lumenis Company for dental laser division.Today he is a luminary doctor of Syneron Company for the dental laser division

The use of the low level laser therapy, good energies, B-Cure® Laser (808 nm), in a laser-assisted dentistry.

Cases report:1 - A 68 years old male (U.N), Upper right quadrant, Extraction of 4 teeth: 11(8), 12(7), 13(6), 14(5) and insertion of 6 implants at the location of 11(8), 12(7), 14(5), 15(4) 16(3) 17(2). Implants at location of 15(4) 16(3) 17(2) flapless implants, pre -op and post -op application of the B-Cure® Laser for 6 minutes. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day. No swelling and no pain, he didn't use the pain killer at all. At 10 days the patient returned to remove the stitches and there were. After 1 month the soft tissue was healed. Evaluation of the area showed complete healing and no complication: There was sealing of the soft tissue around the implants.

B-Cure® Laser treatment for various dental indications

4.9 Case studies - mouth and jaw

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2 - A 39 years old female (H.A) presents in my clinic with chief complain of mobility of tooth # 21 (9). No medical history. Clinical examination revealed mobility grad 3. Periodontal probe indicate depth pocket of 9 mm and bleeding on probing. Radiographs revealed horizontal and vertically bone loss due to periodontal disease around tooth # 21 (9). A flap was raised, ablation of granulation tissue with the erbium laser insertion of implant no submerged and GBR technique, and primary closure. Pre-op and post op application of the B-Cure® Laser for 6 minutes. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day. No swelling at all and no pain, she didn't use the pain killer. Usually a day post op, after GBR technique, there is a big swelling

3 - A 63 years old female.(A.A) 4 month ago I finished full upper jaw rehabilitation in which I inserted 7 implants. A fistula appeared at the buccal of implant at the location of tooth # 24(12) - The diagnostic is Periimplantitis. Pre-op application of the B-Cure® Laser for 6 minutes. A flap was lifted and the granulation tissue was ablated with the Er: YAG laser and GBR technique and primary closure. Application of the B-Cure® Laser for 6 minutes more. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day with a moderate swelling and no pain. The patient was asked to use the B-Cure® Laser for 6 minutes more.

4 - A 40 years male (S.N) present in my clinic with sever pain from tooth # 26 (14) X-ray shows radiolucency area around the apex. Pre-op application of the B-Cure® Laser the tooth pulled out sub anesthesia it was a surgical procedure with stitches. Post op application of 6 minutes more with the B-Cure® Laser. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day no pain and no swelling.

5 - A 58 years old female(T.O). Implant with Periimplantitis at the location of tooth # 12(7). Teeth 11(8) and 21(9) with mobility grad 3. Pre-op 6 minutes application of the B-Cure® Laser. A flap was lifted from 13(5) till 23(11). Extraction of 11(7) and 21(9) insertion of implant at the location of 22(10), Periimplantitis treatment and GBR technique and primary closure of the flap. Post op application of 6 minutes more with the B-Cure® Laser. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day no pain and moderate swelling.

6 - A 60 years old male(H.S), Tooth #14(5) presents a root fracture with a radiolucency area which engulfs the 2 roots of the teeth. Pre-op: 6 minutes application of the B-Cure® Laser .A flap was lifted from the mesial side of tooth #13(6) till the distal side of tooth # 16(3).Extraction of # 14(5) with chiuretage and insertion of implant at the location of tooth #15(4). Primary closure of the flap. The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day no pain and no swelling. Post op application of 6 minutes more with the B-Cure® Laser.



7 - A 30 years old female (I.V). Fistula from 21(9). In the past swelling and pain. X-ray revealed radiolucency area around the apex of 21(9) and 11(8). Pre-op application of 6 minutes of B-Cure® Laser. Apicoectomy had been done for the two teeth. With a massive bone losses which require GBR- (guided bone regeneration). Post op application of 6 minutes more with the B-Cure® Laser.The patient was prescribed antibiotics and pain killers and was advised to maintain good oral hygiene. The patient returned for his first follow-up the next day with moderate pain and moderate swelling. The flap was close. Application of 6 minutes more with the B-Cure® Laser.

8 - A 68 years old male (U.N), upper left quadrant. (The same patient from case No-1). Pre-op application of 6 minutes of B-Cure® Laser. Extraction of teeth #22(10), #24(12), #26(14) and 3 immediate implants. Insertion of 2 flapless implants at the location of teeth # 25(13) and #27(15). Post op application of 6 minutes more with the B-Cure® Laser. This time we decided not prescribe antibiotics or pain killers. We talked to him on the phone and he didn't complain about pain. The patient returned for his first follow-up 2 day later with no pain and no swelling.

Results:Normally, a day after surgical procedure such as implants, Periimplantitis, epicoectomy, surgical extraction, periodontal surgery etc. the patient presents swelling and pain. With the use of Good Energies B-Cure® Laser for 6 minutes before and after and a day after:A- There is hardly any swollenness, the pain is either moderate or none, and in most of the cases there

is no need for more than 1 tablet of pain killers. B- The healing process of the gums is something better and fasterC- There were no side effects.

Conclusions:The use of the of Good Energies B-Cure® Laser, has a positive influence on healing process of the hard and soft tissue, in the mean of less pain less swelling and faster healing.

Figure no.1 shows the big swelling a day later, after GBR technique. Without using the B-Cure



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Dear Erika Carmel,

It is my pleasure to write for you following the use of B-Cure laser Dental Pro.

Husam Abu Diab, 3-1-2014, Orthodontist

I start using the B-Cure laser for three months, I used it to accelerate the healing forthe facial areas in 4 patients who were undergone an orthognathic surgery, eachpatient used it in a weekly fifteen minutes session in the waiting room before thedental check, I also used it for a patient who had a surgical removal of a tumor ofhis lower jaw, also a weekly 8 minutes session, I used it for many patients havingproblems and pain in the temporomandibular joint, 8 minutes session every twodays, I also used it to cure my deep cut injured thumb.

For a special case i used the B-cure laser Dental Pro to a patient after bimaxillaryorthognathic surgery and the healing process was fast and amazing , 10 minutesthree times a day for about one week at home use, the result you can see in theattached photo.

I assure you that the results were shocking and amazing, some patients reportedimmediate relief and others reported some relief after they go home.

I strongly recommend the use of (LLLT) B-Cure Dental Pro for the general dentistryclinics as well as for specialists , as it is small in size which makes it easily portableand handled, it is also rechargeable, easy to use, and more importantly it givesamazing results and relives pain immediately.

Sincerely,

Dr. Husam A.Diab

Orthodontist

B-Cure® Laser treatment post bimaxillary orthognathic surgery


B-Cure® Laser treatment of peri-implantitis


Dr. Avi Reyhanian, Israel

Pro in a laser assisted Peri-implantitis treatment and GBR technique. Certain complications may be experienced with Osseo integration dental implants such as peri-implantitis which is an inflammatory reaction with advanced breakdown of soft and hard tissue surrounding endosseous implant. This potentially leads to implant loss, with the following clinical signs - bleeding in probing, probing depth, suppuration, x-ray and bone loss around the implant. Currently, the methods to reconstitute lost periodontal structures (i.e. alveolar bone, periodontal ligament, and root cementum) have relied on conventional mechanical, anti-infective modalities followed by a range of regenerative procedures including - The treatment of peri-implantitis through surgical treatment- open debridement combined with surface

decontamination and regenerative methods such as guided bone regeneration The treatment of the contaminated implant surface by mechanical and chemotherapeutic

(Air powder, citric Acid, plastic curettes and antiseptic therapy) means has met with mixed success. In addition to conventional treatment modalities the use of the Er:YAG laser 2940 nm, combined with the use of the, B-Cure® Laser Dental Pro has been increasingly proposed for the treatment of peri-implantitis. The use of the Ee:YAG laser has been proposed for cleaning and detoxification of implant surface, it has good potential to remove cytotoxic bacterial components from implant surface, without altering surface morphology and without leading to any thermal damages to the surrounding tissue.The use of the B-Cure® Laser Dental Pro has been proposed for both pre and post-operation treatment by administration of 6 minute pre-op, and post-op administration for a week, 3 times a day. The use of the B-Cure® Laser Dental Pro demonstrates better patient recovery with less swelling and pain. The B-Cure® Laser Dental Pro has become an invaluable tool for many surgical procedures in my clinic, by offering patients faster, less stressful oral therapy with enhanced outcomes.

B-Cure® Laser Dental Pro Case Study in peri-implantitis

Immediately Post-Op After one week treatment Post-Op with B-Cure Laser Dental Pro

The use of the Er-YAG laser 2940 nm togetherwith the B-Cure® Laser Dental

Doctors’ Reviews

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B-Cure Laser treatment for pain in the musculoskeletal system-a personal review.

Introduction:Pain somewhere in the musculoskeletal system is one of the commonest of all symptoms. The cause may be trauma, inflammation, or degeneration. Its severity can be assed only subjectively by the patient himself. Most commonly we need to give a non-invasive symptomatic treatment. Such a treatment should ideally conform to a primary principle in medicine: “primum non nocere”---above all do not do harm! This is why I purchased several B–Cure Laser instruments for trial by my patients.

Scientific background:An extensive experimental literature exists on the biological effect of low level laser (LLL). In experimental brain trauma it has been shown to reduce the post trauma induced inflammatory reaction and the extent of brain cell death, and promote healing and synaptogenesis in mice and rats (1,2,3) . Also in experimental stroke a rat model of arterial occlusion showed that ” low level laser therapy may provide significant functional benefit in stroke….” (4). Low level laser has been effective in potentiating the healing action of human bone marrow mesenchymal stem –conditioned medium in open skin wound healing in diabetic rats (5). Similarly LLL potentiated beneficial biomechanical strength in combination with alendrolate in osteoporotic rats (6). These just a few examples of the biological healing effects on various tissues.

Clinical review (personal and the literature):

Low back pain:Huang et al (6) in a systematic review and meta-analysis of non-specific low back pain (total of 394 patients) conclude that LLL therapy is an “effective method of treatment for relieving pain in non-specific low back pain”. Zdrodowska and associates(7) compared low level laser therapy to magnetic therapy in 120 patients suffering from lumbar disc herniation without neurological deficit and found that “ a greater analgesic effect and greater mobility with the use of the low level laser” . My own experience is good with acute lumbago but doubtful with chronic low back pain. The use of the B-Cure Laser for back pain requires a therapist (friend or family member) since it is difficult for the patient to apply the instrument properly by himself.

Shoulder pain:Taheri and associates (8) compared low level laser with shock wave therapy in myofacial pain in the trapezius muscle : whereas both were effective the low level laser was optimally faster . My own series of 3 partial RC tears reported pain improvement after 5-7 days treatment together with active muscle strengthening. In 4 cases of sub-achromial bursitis and impingement syndrome two decided they felt

Prof. N. D. Reis, F.R.C.S.E. Emeritus Associate Professor Orthopedic Surgery,

Technion, Israel Institute of Technology

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definite relief and two gave up after 3 weeks without any clear-cut benefit . Thornton et al (9) feel that the place of LLL for various painful shoulder conditions is as yet unclear.

Neck pain:Chow et al (10) published their systematic review and meta-analysis of LLL in the management of neck pain in the “Lancet”: they conclude that “LLL reduces pain immediately after treatment in acute neck pain and up to 22 weeks after completion of treatment for chronic neck pain “. The Swedish Council on Health Technology assessed neck pain treated by LLL (11): it concluded that LLL can provide relief from pain for 2-6 months after cessation of treatment. No side effects were encountered. More well executed studies are necessary. My own experience is similar to that of LLL in acute low back pain. Acute neck pain frequently responds to LLL treatment.

Plantar fasciitis:Jastifer and colleagues (12) treated plantar fasciitis with LLL twice weekly for 3 weeks. They conclude: “LLL is a promising treatment for chronic plantar fasciitis.” Macias and his associates (13)report on 69 cases enrolled in a placebo controlled study. They conclude similarly that “ LLL therapy is promising treatment for plantar fasciitis. My own cohort of 5 cases treated twice daily for one month resulted in 3 cases of complete relief , one case of doubtful improvement, and one complete failure.

Epicondylitis—Tennis elbow:I have treated only one case with an excellent response after two weeks of twice daily treatments. I recommended continuation of treatment for a further month although the patient was asymptomatic. So far improvement was maintained after 12 weeks.Roberts et al (14) and Tonk et al (15) report improvement in the use of LLL for tennis elbow (although the laser specifications were not identical to the B-Cure instrument).

Carpal Tunnel Syndrome.Lasovic et al (16) report on a placebo controlled double blind study of 79 patients with CTS. They found pain reduction and NCSEMG improvement in the LLL treated group only.My own experience is that of short term improvement in two cases of CTS without motor weakness after twice daily treatment with the B-Cure Laser for one month. No long term follow up is available.

Knee Joint Pain:Ip (17) followed up 100 cases of bilateral painful osteoarthritis of the knee for 6 years. One group received physical therapy only whilst the second group had additional LLL treatment. The need for knee joint replacement was greatly reduced in the LLL treatment group. Ip and Fu (18) also found that six monthly hyaluronidase intra-articular injections injections combined with LLL treatment were superior to hyaluronidase alone in prolonging the longevity of the knee joint.Nakamura and associates (19) treated 35 patients with osteoarthritis if the knee with LLL and concluded that LLL therapy “ was an effective form of treatment for chronic knee pain caused by knee osteoarthritis”. Similarly Youssef et al (20) investigated the effect of an exercise program with or without LLL treatment in elderly patients . They conclude that the addition of LLL is more effective than exercise alone. I have two patients who purchased the B-Cure laser and treat their arthrotic knees on an ongoing basis. They report that pain is lessened and as result standing and walking ability is improved.

Tedinopathy and insertional tendinosis:Nogueira and Junior (21) searched the databases for the effect of LLL on tendinopathies. Three articles compared the treated group to placebo. They conclude that “ LLL therapy demonstrates consistent results in tendinopathy”. Personally I have as good results in trigger finger and MRI proven trochanteric insertional tendinopathy of the gluteus medius tendon (one case had spectacular relief following ten days of treatment after having suffered months of pain on walking; the other had partial relief only followed by complete cure after a steroid injection.. A severe extension sprain of a PIP joint of the middle finger failed to respond. A severe Achilles re- insertional tendinopathy after a Haglung deformity operation also failed to improve.

Ankle Spain:Stergioulas (22) describes the enhanced reduction of swelling after ankle sprain when LLL is combined with ice packs. My own experience is limited to two cases of basketball players with ankle sprains: both reported lessening of pain after LLL therapy.

General:Cotler and colleagues (23) review “the use of LLL therapy for musculoskeletal pain”. This excellent wide ranging review concludes its discussion as follows: --“ the acceptance of LLL therapy ( which is currently being used by many specialties around the world) into the armamentarium of the American health care provider would allow for additional options for patients. A new cost effective therapy for pain could elevate quality of life while reducing financial strains.

Discussion:My results of treatment for pain cannot be anything but anecdotal and subjective since no control group is presented. Nevertheless these results show that the B-Cure Laser is a useful tool for a wide variety of painful conditions. It can be used as a specific primary treatment or as an adjuvant therapy. The absence of any complications makes it preferable for symptomatic treatment by NSAIDS and local injection therapies (associated with common complications.. Once again “ Primum non nocere !” makes B-Cure laser a wise primary symptomatic treatment.Patient compliance and satisfaction has been good even when the result of treatment was not spectacular. The instrument is aesthetic and fits easily and comfortably into the hand . Hence Low Level B-Cure Laser treatment is extremely convenient. The treatment is at home with no need to travel to physiotherapy departments. It is painless and harmless . The treatment is self-administered with no need for the presence of a therapist, although at certain pain sites self administration is inconvenient: spine and posterior aspect of the shoulder

Conclusion:The B-Cure Laser is a very useful totally harmless analgesic therapy for musculo-skeletal system pain. It may also play a curative biological role in trauma and inflammation such as has been shown in the animal experiments. It is useful to have the instrument at home for it to be immediately available for any common acute pain such as acute lumbago, ankle sprain, muscle strain, torticollis, and heel spur etc…..

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5. Doctors’ reviews

July 15, 2013

TO: The Ministry of Defense, Tel AvivRe: Treatment of Disabled Ministry of Defense Veterans with Soft Laser.Greetings,

In view of experimental treatments with soft laser during the last 23 years, and my knowledge of the literature on the subject, I was asked by Mr. Mickey Shlisser, to prepare background material and indications for the possible introduction of a home laser treatment device for the disabled of the Defense Ministry.Background:Throughout the years of medical history, therapists have predicted the use of the healing power of the sun, “the sun of justice will arise with healing in its wings” Malachi 3:20 and there have been many forms of light therapy offered.During the past 60 years there has been meteoric development in laser technology currently used in many industries and in medicine.The acronym LASER stands for: Light Amplification by Stimulated Emission of RadiationThe laser is a monochromatic electromagnetic coherent wave, with a constant wavelength, which is capable of transfering a certain amount of energy to a very narrow focal point and with good penetration ability. Lasers can be used with a single beam or with a cluster of beams.Repeated studies have shown that a wave length between 600-900 nm at the intensity of 1-1000mW, does not cause heat or damage, however it is highly effective and highly –functional working on tissue and on an intracellular and systemic level.The term LLLT (Low level Laser therapy) Is currently the most widely accepted to distinguish between “Soft Laser” – the laser used for therapy, and “Hard Laser“ -used for surgery. Terms used in reference to LLLT are Soft Laser, or Cold Laser or Low intensity Laser, or Low Level Laser. The effect of the laser is at the tissue level, reducing inflammatory components in the treated area, such as E2, Prostaglandin, endoperoxide synthase 2, interleukin 1-beta, and tumor necrosis factor-alpha.This lower Neutrophil Granulocytes, brings about less oxidative stress, less swelling and bleeding.On the cellular level, the cytoplasma, the impact on the ADP by means of the mitochondria thus changes the cellular homeostasis, activating inter cellular enzymes, increasing ATP through the energy of the laser. The deviceIsraeli development of the B-Cure® Laser expanded the width of the beam and provided an opportunity to illuminate an area of about 4.5 square centimeters, of coherent monochromatic laser beam, at a wavelength of 808nm at the intensity of 250mW.The effective depth of penetration of this intensity of laser beam into the soft tissue is up to 4 cm under


the skin. The energy goes up to 6 Cm at this depth but with low impact. No side effects are known, there is no known damage caused by treatment doses over and above the recommended therapeutic window. There is only one stipulation: to avoid directly looking at the beam with the eye.In view of the above presentation and background, and given the many studies performed on soft laser therapy and the literature of the last twenty years, and in light of my familiarity with the B-Cure® Laser, and the medical needs of disabled IDF veterans, I will detail below the recommended indications. Indications for the treatment of disabled IDF veterans.Tendinitis treatment of all kinds: *For example:Levator scapula Tendinitis, Bicipital tendinitis, DeQuervain’s Tendinitis, Trigger finger, Pez ancerinus Bursitis, Trochanteric Bursitis (in skinny people), runners knee (Biceps femoris tendinitis), Jumper’s knee (Patellar Tendon Tendinitis), Achiles tendinitis, Plantar Fasceitis.

Treatment of arthritis of small joints;For example, temporomandibular joint disorder, shoulder pain, joints of the fingers, wrist pain, pain after healing fractures, or failure of carpal bone healing, pain due to inflammation in the joints of the feet Arthritis...Treatment of wounds that are not healing: *Diabetic lesions, neuropathic wounds.Treatment of acute injuries: *Painful areas and absorbed hematomas, contusions and Intramuscular hematomas. Periodontal therapy treatment after periodontal surgery extractions and stitches (there is a specific device for this purpose with increased power for handling periodontal treatments).Treatment of back and neck pain is not specific: *Radiating to the trigger points and stiff muscles and sore points.* Please note that treatment does not replace diagnosis and treatment by a doctor, but could well used for symptomatic treatment of pain in many cases of muscular pain and as complementary treatment to the physical therapy.Bio-mechanical treatment of chronic injury situations:There are situations after injuries, where there is deformation or damage to bio mechanical strength, permanent and chronic damage. This disorder causes pain due to muscle action that causes a continuous load on the abernetic muscles at fixed points, and leads to chronic pain.These people generally consume many drugs long term, which are disruptive and damaging to various systems. These cases can be treated by soft laser whenever there is increased pain, and maintenance treatment to prevent worsening.In conclusion:It appears to me that there is room to bring this treatment in as an alternative for symptomatic analgesic invalids; according to all of the above, and subject to EBM,IDF being in accordance with all the above indications.

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November 6, 2013To: Erika Carmel LTD.,

Re: Review of the use of the B-Cure® Laser device for people engaged in vigorous physical activity.

Shalom, In the course of the physiotherapy given to the Olympic sports team and competitive sports teams at the Wingate Institute, we have recently been using the Erika Carmel Ltd. B-Cure® Laser device both in our clinic and for treatment at home. These treatments have been administered in a variety of acute and chronic cases, including a number of severe injuries to athletes who were to participate in designated competitions within a short period of time.The B-Cure® Laser device is user friendly, light and mobile. In addition to the device used in the clinic, there is a device adapted for personal home use by the patient. We see fit to report our great satisfaction regarding pain relief and improved functionality achieved through the use of the device in combination with other methods of treatment. We have registered good response and persistence in treatment, in addition to the satisfaction expressed by the athletes, regarding the support and guidance they received from the company’s support team. We certainly recommend using the B-Cure® Laser device as part of the effective treatment for wounds and sports injuries as well as for post surgical recuperation. Amongst the advantages of using the B-Cure® Laser device you can expect:Reduced pain in cases of overload such in with “shin splints” and other similar syndromes, thereby preserving strength for both athletes and other competitive sports participants, thus decreasing the number of absences from training and /or partial functionality during physical activity.Reduced pain and shortening of recovery time from injuries (especially superficial ones such as ankle sprains and similar issues).Efficient field treatment for cramps, muscle strains etc during strenuous or long training (back ache, rotator cuff pain- shoulder girdle and knee pain).B-Cure® Laser treatment significantly reduces the use of anti inflammatory drugs known to have many side effects.

Sincerely,Dr. Luba Galizkaya, Olympic Doctor, Wingate Institute.Dr. Maya Kalla –Benzur, Head of Physiotherapy, Wingate Institute


Using the B-Cure® Laser device

During the past two years there has been extensive use of the B-Cure® Laser device at my clinic. Amongst the musculoskeletal problems of patients where the device was used successfully:Inflamed knee tendons including VMO muscle inflammation, upper patella tendonitis, and rear knee muscle pain.Pain in the lower limb resulting from injury to the ligaments of the ankle, knee or thigh.Wrist pain resulting from overusing the mouse and keyboard.Hip joint pain as a result of erosion and the implications to the supporting tissue.Contusions and injuries to muscles and the secondary joint inflammation these cause.Muscle pain in the foot – plantar fasciitisCoccyx pain (Coccydynia).Use of this device supports faster recovery and return to functional and athletic activity.

Dr. Nimrod LiramHead of Chiropractics Hadassah Ein Kerem HospitalJuly 2014

Certificates and Approvals

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6. Certificates and Approvals

Biocare Enterprise LTDRm 1301, 13/F, Chinachem Tsuen Wan Plaza, 457 Castle Peak Road, Tsuen Wan, N.T. Hong Kong.

Distributor: Erika Carmel LTD 5 Nachum Heth St., Hi-Tech Park, Haifa 3508504, Israel. Tel: +972-73-7293001/2 | E-mail: [email protected] www.gd-energies.com

Authorized Representative: Obelis SA Bd General | Wahis 53 1030 Brussels, Belgium Tel: +(32) 2-732-60-03 | Fax: +(32) 2-732-59-54 | [email protected]

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Efficacy of B-Cure® Laser therapy for a wide variety of ... · for a wide variety of clinical indications in modern medicine ... implants, orthodontics, root canal treatment,