SPA THERAPY AT THE DEAD SPA THERAPY AT THE DEAD SEA AREA FOR ANKYLOSING SEA AREA FOR ANKYLOSING

SPONDYLITISSPONDYLITIS

Sukenik S., Kudish S.,Dubrowinski S., Sukenik S., Kudish S.,Dubrowinski S., Flusser D. and Abu-Shakra M.Flusser D. and Abu-Shakra M.

Soroka University Medical CenterSoroka University Medical CenterFaculty of Health SciencesFaculty of Health Sciences

Ben-Gurion University of the NegevBen-Gurion University of the NegevBeer-Sheva, IsraelBeer-Sheva, Israel

Previous Studies At The Dead Previous Studies At The Dead Sea AreaSea Area

Inflammatory ArthritisInflammatory Arthritis

Rheumatoid ArtritisRheumatoid ArtritisAnn Rheum Dis 49:99, 1990Ann Rheum Dis 49:99, 1990Is J Med Sci 31:210, 1995Is J Med Sci 31:210, 1995Clin Rheumatol 11:243, 1992Clin Rheumatol 11:243, 1992Harefuah 129:100, 1995Harefuah 129:100, 1995Rheumatol International (in press)Rheumatol International (in press)

Psoriatic ArthritisPsoriatic ArthritisJ Rheumatol 21:1305, 1994J Rheumatol 21:1305, 1994Isr Med Assoc J 3:147, 2001Isr Med Assoc J 3:147, 2001Isr Med Assoc J 3:828, 2001Isr Med Assoc J 3:828, 2001

Non-Inflammatory ArthritisNon-Inflammatory Arthritis

OsteoarthritisOsteoarthritis

Harefuah 129:100, 1995Harefuah 129:100, 1995

Isr Med Assoc J 1:83, 1999Isr Med Assoc J 1:83, 1999

FibromyalgiaFibromyalgia

Clin Rheumatol 20:15, 2001Clin Rheumatol 20:15, 2001

Rheumatol International 20:105, Rheumatol International 20:105, 20012001

Treatment Modalities At The Dead Treatment Modalities At The Dead SeaSea

- Dead Sea waterDead Sea water

- Thermo-Mineral springsThermo-Mineral springs

- MudMud

- PhysiotherapyPhysiotherapy

- HeliotherapyHeliotherapy

Dead SeaDead Sea- The Lowest Spot On The Face Of The Lowest Spot On The Face Of The Earth – 400 m Below Sea LevelThe Earth – 400 m Below Sea Level

- Length – 50 kmLength – 50 km

- Width 17 kmWidth 17 km

- Terminal LakeTerminal Lake

- One Of The Saltiest Lakes One Of The Saltiest Lakes In The WorldIn The World

- Average Salinity 345 gr/lAverage Salinity 345 gr/l

Important Climatic FeaturesImportant Climatic FeaturesWorld’s highest barometric pressureWorld’s highest barometric pressure

Low relative humidity (33-50%)Low relative humidity (33-50%)

High temperatures (summer 32-40High temperatures (summer 32-4000c,winter 20-32c,winter 20-3200c)c)

Low rainfallLow rainfall

Clear sunny skiesClear sunny skies

High UVA/UVB ratioHigh UVA/UVB ratio

Pollen low atmospherePollen low atmosphere

Oxygen-rich air – 6-8% more molecules per mOxygen-rich air – 6-8% more molecules per m33

Ideal Weather Conditions For Ideal Weather Conditions For Patients Suffering From ArthritisPatients Suffering From Arthritis

High barometric PressureHigh barometric Pressure

Low relative HumidityLow relative Humidity

High Constant TemperaturesHigh Constant Temperatures

Hollander et al – Transaction of the New-York Academy of Science, 1961

Summary Of Previous StudiesSummary Of Previous Studies

- Short term improvement in most of Short term improvement in most of the clinical parametersthe clinical parameters

- Discordance between clinical and Discordance between clinical and laboratory parameterslaboratory parameters

- Very few side effectsVery few side effects- Very few contraindicationsVery few contraindications- Cannot substitute conventional Cannot substitute conventional

therapy but can complement ittherapy but can complement it

Aim Of Present StudyAim Of Present Study

To assess the efficacy of the unique To assess the efficacy of the unique climatic conditions at the Dead Sea climatic conditions at the Dead Sea

versus balneotherapyversus balneotherapy

Patients and Methods (1)Patients and Methods (1)

28 Pts – Ankylosing Spondylitis

Inclusion CriteriaInclusion Criteria- ACR diagnostic criteria for AS- ACR diagnostic criteria for AS- Active disease – back pain- Active disease – back pain

Exclusion CriteriaExclusion Criteria- Psoriasis- Psoriasis- Malignancy- Malignancy- End stage renal or liver diseases- End stage renal or liver diseases- Mental disorders- Mental disorders- Spinal diseases- Spinal diseases

Patients And Methods (2)Patients And Methods (2)

Pts were randomly allocated:Pts were randomly allocated:

Balneotherapy group – 14 ptsBalneotherapy group – 14 pts

Daily Treatment with: Daily Treatment with:

1.Mud packs – 39-401.Mud packs – 39-4000cc

2.Sulfur pool – 36-372.Sulfur pool – 36-3700cc

LakeLake

3.Dead sea water 3.Dead sea water

indoor indoor poolpool

Patients And Methods (3)Patients And Methods (3)

Climatic group – 14 ptsClimatic group – 14 pts

No balneotherapyNo balneotherapy Sweet water poolSweet water pool

Duration of treatment: 2 weeksDuration of treatment: 2 weeks

Patients And Methods (4)Patients And Methods (4)

Patients Assessments:Patients Assessments:- 1-2 days prior to arrival1-2 days prior to arrival- End of treatment period (2 weeks)End of treatment period (2 weeks)- One monthOne month- Three monthsThree months

All pts were assessed by a single All pts were assessed by a single rheumatologistrheumatologist

Blinded to the mode of therapyBlinded to the mode of therapy

Patients And Methods (5)Patients And Methods (5)

Parameter measured at each assessment:Parameter measured at each assessment:- Bath AS disease Activity Index (=Bath AS disease Activity Index (=BASDAIBASDAI))

- Physical examinationPhysical examination

- Patient’s evaluation of disease:Patient’s evaluation of disease:VASVAS-pain-pain

severity:severity:VASVAS- limitation of movement- limitation of movement

- SF-36 : Quality of life QuestionnaireSF-36 : Quality of life Questionnaire

Baseline Characteristics of study participants. Baseline Characteristics of study participants. Number ± SD or NumberNumber ± SD or Number(%) (%)

Balneology group N=14

Climatic group n=14

p

Sex Male

Female

12

2

14

0

0.48

Age (years)49.7 ± 12.046.1 ± 13.40.46

Disease duration17.1 ± 13.318.6 ± 12.20.77

Use of medication

Pain killers

Narcotics

NSAIDs

7) 50%(

0

9) 64.3%(

4) 28.6%(

1) 7.1%(

8) 57,1%(

0.22

0.5

0.5

Routine physical therapy1) 7.1%(00.5

Initial BASDAI4.9 ± 2.0 1.5 ± 6.10.07

Initial VAS for pain6.7 ± 2.22.4 ± 6.4 0.75

Initial VAS limitation in movement6.3 ± 2.4 1.6 ± 7.10.28

Initial morning stiffness (minutes)46.3 ± 32.948.6 ± 74.30.1

BASDAI scores at the four assessments BASDAI scores at the four assessments by treatment group. Average by treatment group. Average ± SD SD

Balneotherapy group n=14

Climatic group n=14

Study initiation4.86 ± 1.986.10 ± 1.47

End of treatment at Dead-Sea area

3.96 ± 1.584.16 ± 2.18 *

One month follow-up4.83 ± 1.594.67 ± 1.56 *

Three months follow-up

4.77 ± 1.674.86 ± 1.96

BASDAI: Bath Ankylosing Spondylitis Disease Activity Index

* P < 0.05 – in comparison to pretreatment values

Results of VAS Scores for Pain and for Results of VAS Scores for Pain and for Movement Limitation. Average Movement Limitation. Average ± SD SD

Balneotherapy group n=14

Climatic group

n=14

PainMovementPainMovement

Study initiation6.7 ± 2.26.3 ± 2.46.4 ± 2.47.1 ± 1.6

End of treatment at Dead-Sea area

4.4 ± 2.2 *5.9 ± 2.24.4 ± 2.5 *5.1 ± 2.3 **

One month follow-up

5.2 ± 2.5 **5.9 ± 1.85.1 ± 2.15.4 ± 2.1 **

Three months follow-up

5.1 ± 2.7 *6.1 ± 2.04.9 ± 2.55.6 ± 2.2 **

VAS: Visual Analog Scale (Scale 1-10)

** P < 0.05P < 0.05* ** * P < 0.01 P < 0.01

BASDAI Scores at The Four BASDAI Scores at The Four Assessments of All PatientsAssessments of All Patients

ALL PATIENTS (28)

Study initiation5.48 ± 1.82

End of treatment4.06 ± 1.87 * *

One month follow-up4.75 ± 1.55

Three months follow-up4.81 ± 1.78

* ** * P < 0.01 – in comparison to pretreatment value

Results of selected physical examination tests, Results of selected physical examination tests, regardless of treatment group (n=28). All values are in regardless of treatment group (n=28). All values are in

centimeters, Average centimeters, Average ± SDSD

Assessment Assessment 11 was performed immediately before leaving for the Dead-Sea area, was performed immediately before leaving for the Dead-Sea area,Assessment Assessment 22 was performed immediately before leaving the Dead-Sea area, was performed immediately before leaving the Dead-Sea area,Assessment Assessment 33 and and 4 4 were performed one and three months after completion of were performed one and three months after completion of therapy, respectivelytherapy, respectively..

Assessment periodAssessment period

11223344ppWall-occiput distance

10.5 ± 8.710.2 ± 8.710.5 ±8.811.1 ± 90.780.78

Chest expansion3.5 ± 4.73.3 ±1.53.3 ± 1.23.6 ± 2.40.970.97

Finger 3-floor distance

35.2 ± 11.431.5±11.534 ± 13.533.8 ±12.30.210.21

Schober test2.0 ± 1.33.1 ±2.42.6 ± 1.22.4 ± 1.30.0140.014

Results of the SF-36 questionnaire. Values are on a Results of the SF-36 questionnaire. Values are on a scale between 0 and 100, higher score represent better scale between 0 and 100, higher score represent better

health. Average health. Average ± SD SD..

Balneotherapy group n=14Climatic group n=14

beforeafterbeforeafter

Limitations in physical activities

33.6 ±23.746.4 ±25.345.7± 21.247.5±24.8

Limitation in everyday activities

26.8 ±31.733.9 ±28.830.4± 24.426.8±24.9

Bodily pain27.9 ±19.342.1 ±18.6 *38.0± 19.344.6±22.7

General health perception18.2 ±22.216.1 ±15.622.1± 19.219.6±23.8

Levels of psychological stress and anxiety

47.6 ±38.654.8 ±31.031.0± 27.645.2±31.0

Limitations in social activities

34.8 ±24.140.2 ±18.547.3± 18.549.1±21.1

Emotional role55.1 ±21.950.6 ±20.662.3± 25.069.1±15.7

Energy levels and fatigue37.1 ±15.243.4 ±21.947.1± 18.848.6±24.5

* *p=0.03 compared with value before treatmentp=0.03 compared with value before treatment

SummarySummary

Significant improvement (p<0.05) in Significant improvement (p<0.05) in BASDAI lasting one month was BASDAI lasting one month was observed only in the climatic groupobserved only in the climatic group

The addition of balneotherapy did not The addition of balneotherapy did not show any beneficial effects (except vas show any beneficial effects (except vas for pain)for pain)

SF-36 questionnaire – no significant SF-36 questionnaire – no significant improvement in both groupsimprovement in both groups

Previous StudiesPrevious StudiesTishler et al, Clin Rheumatol 1995; 14:21

Uncontrolled Pilot StudyUncontrolled Pilot Study

14 pts treated with14 pts treated with

- Hot spring water- Hot spring water

- Mud packs- Mud packs

Duration: 2 weeksDuration: 2 weeks

ResultsResults::

Significant Improvement:Significant Improvement:- Morning stiffness- Morning stiffness- Finger to floor distance- Finger to floor distance- Overall well-being- Overall well-being- Reduction in use of NSAID’s- Reduction in use of NSAID’s

Improvement began after one week Improvement began after one week last – three monthslast – three months

Previous Studies (2)Previous Studies (2)Hashkes P. – Scand J Rheumatol 2002; 31:172

Duration – 4 weeksDuration – 4 weeks

53 pts53 pts

Mode of therapy-climatotherapy + different Mode of therapy-climatotherapy + different modalities of balneotherapy + physiotherapy modalities of balneotherapy + physiotherapy UncontrolledUncontrolled

No follow-up examinationsNo follow-up examinations

ResultsResults::60% (32/53) – Responders60% (32/53) – Responders

Responders:Responders:At least 20% improvement in 3 of the following 4 At least 20% improvement in 3 of the following 4 criteria:criteria:

- Morning stiffness- Morning stiffness- Pain intensity- Pain intensity- Patient global assessment- Patient global assessment- Bath as functional index- Bath as functional index

A. S. males responded more often than femalesA. S. males responded more often than females

Previous Studies (3)Previous Studies (3)Tubergen et al – Arthritis Care and Research 2001; 45:430

Group 1Group 1 – 40 pts – 40 pts

3 weeks-SPA therapy3 weeks-SPA therapy

(At Bad Hofgastein, Austria)(At Bad Hofgastein, Austria)

Group 2Group 2 – 40 pts – 40 pts

3 weeks-SPA therapy3 weeks-SPA therapy

(At Thermalbad, Arcen, Netherlands)(At Thermalbad, Arcen, Netherlands)

Group 3Group 3 – 40 pts (control) – 40 pts (control)

Standard treatment at homeStandard treatment at home

Tubergen et al – Arthritis Rheum 2002; 47:459

120 pts – randomized, prospective controlled Study120 pts – randomized, prospective controlled Study

After intervention weeksAfter intervention weeksAll patients- weekly group physical therapy for 40 weeksAll patients- weekly group physical therapy for 40 weeks

ResultsResults::

Combined SPA – exercise therapy Combined SPA – exercise therapy (group 1,2) is superior to standart (group 1,2) is superior to standart therapy (group 3)therapy (group 3)

Beneficial effects at least 40 weeksBeneficial effects at least 40 weeks

Favorable cost – effectiveness and Favorable cost – effectiveness and cost – utility ratioscost – utility ratios