INFORMATION & INSPIRATION FOR LIVING WITH PAIN

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CRP

S Complex Regional Pain Syndrome:

V I A BLE PAT IEN TPAT HWAYS TO RELIEF

Unfortunately, chronic pain is far too common. According to the Institute of Medicine1, an estima- ted 100 million Americans are affected by chronic pain. Neuropathic pain, including CRPS, represents one of the most prevalent yet undertreated chronic pain conditions currently facing patients today, with an estimated 3 -4.5 percent of the global pop-ulation suffering from the condition2.

Patients struggling with chronic pain may also pres-ent with co-occurring conditions affecting their quality of life such as poor sleep, inactivity, or de-pression and anxiety, which may strain their per-sonal relationships3. The overall impact on American society is staggering, with health economists from John Hopkins University in Baltimore estimating that Americans spend approximately $635 billion annually on the direct and indirect costs associated with managing chronic pain4.

CRPS: The Facts“Our understanding of CRPS continues to evolve,” said Dr. Timothy Lubenow, a professor of anesthe-siology and chief, section of pain medicine at Rush University Medical Center. “It is believed to develop along skin, nerve and skeletal muscle after trauma or injury, thought to be caused by a malfunction of the central and peripheral nervous systems that af-fect the way pain signals are sent from the brain and spinal cord to the rest of the body.”

Often characterized by prolonged or excessive focal pain in the limbs, CRPS can cause mild or dramatic changes in skin color and temperature, and swelling in the affected area.

There are two types of CRPS: Type I and Type II. Type I, previously called reflex sympathetic dystro-phy (RSD) syndrome, occurs following an injury or illness that didn’t directly damage the nerves in the affected area.5 The diagnosis of CRPS Type II, pre-viously called peripheral causalgia, follows a specific nerve injury.6

“At this time there are no definitive tests that can confirm CRPS, although certain tests can rule out other conditions like Lyme disease or a blood clot,” said Lubenow. “Diagnosis is made by exam and re-view of the patient’s history and symptoms.”

Lubenow went on to explain that the disease varies in duration and severity.

“Research suggests many cases are relatively mild and patients recover gradually over time. However, in severe cases patients may require more aggressive interventions to find some measure of relief,” said Lubenow.

CRPS Preliminary TreatmentsSimilar to other chronic pain conditions, there is no single cure for CRPS, but treatment often involves a combination of approaches that can provide meaningful relief. Exercise, in the form of rehabili-tation therapy, can improve flexibility, strength and blood flow.7 Occupational therapy helps patients improve their functioning with daily tasks.8 Psy-chotherapy can be critically important for chronic pain patients and their families.9 According to the National Institute on Neurological Disorders and Stroke (NINDS), patients with CRPS may develop depression, anxiety or post-traumatic stress disor-

WHEN PATIENTS LIVING WITH CHRONIC PAIN ARE REFERRED TO PAIN MAN-

AGEMENT SPECIALISTS, IT IS OF TEN BECAUSE THEY HAVE ALREADY TRIED MULTIPLE

THERAPY OPTIONS WITHOUT FINDING MEANINGFUL RELIEF. FOR THOSE DIAGNOSED

WITH COMPLEX REGIONAL PAIN SYNDROME {CRPS } OR WHO SUFFER FROM FOCAL

LIMB PAIN, IDENTIF YING EFFIC ACIOUS THER APEUTIC SOLUTIONS CAN BECOME EVEN

MORE CHALLENGING.

FALL 2016 21

der, which can make their pain and physical reha-bilitation more difficult. Some patients benefit from learning biofeedback techniques, which help them become more aware of their body and relieve pain.10

Medication, such as non-steroidal anti-inflammatory drugs, including aspirin, ibuprofen and naproxen may be prescribed, especially in the early stages of the disease. Topical analgesics can reduce hypersen-sitivity11, while corticosteroids treat inflammation, swelling and edema12. A sympathetic nerve block, delivered by injection near the spine, can provide temporary relief and improve blood flow for some patients.13 A sympathectomy is a treatment that has been recommended in the past sometimes for those who show a strong response to sympathetic nerve blocks.14 This has not been shown to have a good sustained long term response. As a last resort pa-tients may try relief from intrathecal drug pumps, which place pain relieving medication directly into the fluid surrounding the spinal cord. NEUROSTIMUL ATIONSpinal cord stimulation (SCS), a form of neuro-stimulation, is a proven therapy that has been rec-ommended by doctors to manage chronic pain and improve quality of life. SCS systems are approved or cleared by the U.S. Food and Drug Administra-

tion (FDA) for the management of chronic pain. It has been used to manage pain that comes from failed back surgery syndrome (FBSS) or post-lam-inectomy syndrome and other neuropathies.

Neurostimulation, however, is not a cure for what is causing the pain and does not treat specific dis-eases. Instead, it is a therapy that’s designed to mask pain by blocking pain signals before they reach the brain. While neurostimulation helps most patients receive at least some reduction in pain, not every-one responds in the same way. Complications from neurostimulation may include painful stimulation, loss of pain relief, and certain surgical risks (e.g. pa-ralysis). Patients should be sure to discuss the risks and benefits of neurostimulation with a doctor.

DORSAL ROOT GANGLION NEUROSTIMULATION THERAPY FDA Approved for CRPSA new type of neurostimulation, called dorsal root ganglion (DRG) therapy, received FDA approval in February 2016 for the treatment of adults with moderate to severe difficult-to-treat chronic pain caused by CRPS of the lower limbs. The DRG is a spinal structure densely populated with sen-sory nerves that transmit information to the brain via the spinal column. The ACCURATE IDE study demonstrated DRG therapy provided superior pain relief in patients with chronic lower limb pain compared to traditional SCS therapy15.

Results from the clinical study, which is the largest study to date evaluating patients suffering from neuropathic chronic intractable pain associated with CRPS or peripheral causalgia, showed a statistically significant number of patients receiving DRG stim-ulation achieved meaningful pain relief and greater treatment success at three and 12 month intervals compared to patients receiving traditional SCS.

“The latest DRG therapy delivers a form of neuro-stimulation that stimulates the dorsal root ganglion, giving physicians the ability to directly treat the specific areas of the lower limbs where the pain occurs,” said Lubenow. “As a result, DRG therapy

22 WWW.PAINPATHWAYS.ORG

Dorsal Root Ganglion (DRG)

FALL 2016 23

is a unique therapeutic approach that provides pain relief to patients with neuropathic conditions who have tried multiple treatment options without re-ceiving adequate pain relief and who are under-served by traditional SCS.”

Key outcomes from the ACCUR ATE IDE16 study include:

··· Superior pain relief: Significantly more patients receiving DRG stimulation achieved pain relief and greater treatment success when compared to patients receiving traditional SCS (74.2 percent vs. 53 percent at 12 months).

··· Consistent therapy: DRG Patients had an average of 81.4% reduction in their pain at 12 months.

··· Precise anatomical pain relief: Aft er receiving DRG stimulation, 94.5 percent of patients did not experience stimulation outside of their area of pain at 12 months*.

While DRG therapy offers an exciting new therapy modality to treat CRPS of the lower extremities, traditional SCS remains clinically effi cacious for other types of chronic pain. Anyone interested in DRG therapy or SCS should consult with their physician to discuss therapy options and personal-ize their chronic pain management plan.

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CITATIONS1 Relieving Pain in America. (2011). doi:10.17226/13172

2 The American Academy Of Pain Medicine. (n.d.). Retrieved August 05,2016, from http://www.painmed.org/library/pain-medicine-journal/

3 Mccarberg, B. H., Nicholson, B. D., Todd, K. H., Palmer, T., & Penles,L. (2008). The Impact of Pain on Quality of Life and the Unmet Needs of Pain Management: Results From Pain Sufferers and Physicians Participating in an Internet Survey.American Journal of Therapeutics, 15(4), 312-320. doi:10.1097/mjt.0b013e31818164f2

4 Gaskin, D. J., & Richard, P. (2012). The Economic Costs of Painin the United States. The Journal of Pain, 13(8), 715-724. doi:10.1016/j.jpain.2012.03.009

5-6 Complex regional pain syndrome. (n.d.). Retrieved August 05,2016, from http://www.mayoclinic.org/diseases-conditions/complex-regional-pain-syndrome/basics/causes/con-20022844

7-8 Stanton-Hicks, M., Baron, R., Boas, R., Gordh, T., Harden, N., Hendler, N., . . . Wilder, P. (1998). Complex Regional Pain Syndromes: Guidelines for therapy. The Clinical Journal of Pain, 14(2), 155-166. Retrieved from http://europepmc.org/abstract/med/9647459

9 NINDS Chronic Pain Information Page. (n.d.). Retrieved August 05,2016, from http://www.ninds.nih.gov/disorders/chronic_pain/chronic_pain.htm

10 Complex Regional Pain Syndrome Fact Sheet. (n.d.). RetrievedAugust 05, 2016, from http://www.ninds.nih.gov/disorders/reflex_sympathetic_dystrophy/detail_reflex_sympathetic_dystrophy.htm

11 Abram, S. (2012). Topical capsaicin for pain management: Therapeuticpotential and mechanisms of action of the new high-concentration capsaicin 8% patch. Yearbook of Anesthesiology and Pain Management, 2012, 403-404. doi:10.1016/j.yane.2012.01.002

12 Barnes, P. J. (2009). How corticosteroids control inflammation:Quintiles Prize Lecture 2005. British Journal of Pharmacology, 148(3), 245-254. doi:10.1038/sj.bjp.0706736

13 Sympathetic Nerve Blocks for Pain. (n.d.). Retrieved August 05,2016, from http://www.hopkinsmedicine.org/healthlibrary/test_procedures/orthopaedic/sympathetic_nerve_blocks_for_pain_135,54/

14 Singh, B., Moodley, J., Shaik, A. S., & Robbs, J. V. (2003, March).Sympathectomy for complex regional pain syndrome. Journal of Vascular Surgery, 37(3), 508-511. doi:10.1067/mva.2003.78

15-16 Levy et al. ACCURATE study presentation. NANS, 2015.

PRIOR TO USING THE A X IUM T M NEUROSTIMULATOR SYS-

TEM, P A T I E N T S S H O U L D R E V I E W T H E U S E R ’S M A N U A L

F O R A COMPLETE LISTING OF INDICATIONS, CONTRAINDI-

CATIONS, WARNINGS, PRECAUTIONS, POTENTIAL ADVERSE

EVENTS AND DIRECTIONS FOR USE.

RESE ARCH AND EMERGING THER APIESAlthough CRPS still remains somewhat unknown, there is continued research being conducted to bet-ter understand this disease. NINDS continues to support research to develop new therapies designed to limit symptoms and disability associated with CRPS. For example, earlier research suggests that inflammation related to CRPS is supported by the body’s natural immune response. According to the NINDS, researchers seeking to understand how CRPS develops want to further understand immune system activation and peripheral nerve signaling. Emerging treatments cited by NINDS include hy-perbaric oxygen therapy, intravenous ketamine and low-dose intravenous immunoglobulin.

CHANGING THE FACE OF CRPS WITH DRG THERAPYPatients with CRPS are often underserved by con-ventional medical management and many inter-ventional pain procedures. The recent approval of DRG therapy ensures these patients have access to a superior therapeutic approach for managing dif-fi cult-to-treat chronic pain of the lower limbs in adult patients with CRPS.

Discover more and fi nd a DRG pain specialist near you by visiting www.sjm.com/painpathways. PP

F

F

Indications for Use: The Axium™ Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** * Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study.**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. Contraindications: Patients contraindicated for the Axium Neurostimulator System are those who are unable to operate the system and are poor surgical risks. Patients who failed to receive e�ective pain relief during trial stimulation are contraindicated to proceed to the INS procedure. Potential Adverse Events: The implantation of a neurostimulation system involves risk. Implant Manual must be reviewed for detailed disclosure. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2016 St. Jude Medical, Inc. All Rights Reserved.SJM-AXM-0716-0042 | Item approved for U.S. use only.

THIS CONTENT WA S SPONSORED BY ST. JUDE MEDICAL, INC.

NEW STUDY

NEWS Y O U C A N U S E

10 WWW.PAINPATHWAYS.ORG

September’sPAIN AWARENESS MONTH

MARKS THE KICKOFF FOR NEW ACPA TOOL KIT:PARTNERS FOR UNDERSTANDING PAIN

During September’s Pain Awareness Month, Partners for Understanding Pain, a consortium of organizations that touch the lives of people with chronic, acute and cancer pain spearheaded by the American Chronic Pain Association and its 60 partner organizations, has developed a tool kit of valuable resources focused on a variety of pain issues with the goal of educating both health care providers and consumers at all levels of treatment and therapy. The tool kit includes a repository of resources offered by partners on their web pages.

ACCESS THE TOOLKIT AT:

HTTPS://THEACPA.ORG/UPLOADS/HEALTH_CARE_PROFESSIONAL _TOOL_KIT_2016.PDF

NEW FULL-BODYMRI-SAFE PAINRELIEF SYSTEM

The new Precision Montage spinal cord stim-ulation is a new advancement in neuromodu-altion pain therapy. As the only system to deliver relief while still allowing patients access to full-body MRI scans, the Precision Montage MRI couples full-body scan access with the most advanced programming to provide excellent pain relief.

FOR MORE INFORMATION:

WWW.BOSTONSCIENTIFIC.COM

People with neuropathic chronic pain associated with CRPS and their care-givers will want to know about a new treatment device option called Axium™. The first and only neurosti-ulation device designed for dorsal root ganglion (DRG) stimulation, the Axium™ Neurostimulator System stim- ulates the DRG, a spinal structure densely populated with sensory nerves that transmits information to the brain via the spinal cord.

FOR MORE INFORMATION:

WWW.SJM.COM/PAINPATHWAYS

PROMISING RESULTS for PHANTOM LIMB PAIN

A clinical trial using a technique called cryoablation—the application of extreme cold—shows good results for those suffering from phantom limb pain (PLP) resulting from amputation.Almost 185,000 people undergo amputations each year in the US, whether resulting from combat wounds, diabetes or other medi-cal conditions. Researchers for this clinical trial believe that cryoablation freezes the nerves and scar tissue at the amputation site, reducing nerve signals to the brain and lowering pain levels.

FOR MORE INFORMATION:

WWW.HEALTHNEWSLINE.NET/NEW-COLD-BLASTS-TECHNIQUE-MAY-EASE-PHANTOM-LIMB-PAIN-AMPUTEES/2535129/

A new study shows that the most common medications (bisphosphonates, including Fosamax® and Boniva®) used

for treatment of hyperparathyroidism, a condition that causes bone loss, may actually increase risk of fractures.

The study of 6,000 people with hyperparathyroidism found that those treated with bisphosphonates suffered

hip fracture at the rate of 86 per 1000. Those who had para-thyroid surgery reported 20 fractures per 1000, and those

who were not treated at all recorded 56 fractures per 1000.

FOR MORE INFORMATION:

WWW.NEWSWISE.COM/ARTICLES/VIEW/651040/?SC=DWHP

PHANTOM LIMB PAINA clinical trial using a technique called cryoablation—the

shows good results for those suffering from phantom limb pain (PLP) resulting from amputation.Almost 185,000 people undergo amputations each year in the US, whether resulting from combat wounds, diabetes or other medi-cal conditions. Researchers for this clinical trial believe that cryoablation freezes the nerves and scar tissue at the amputation site, reducing nerve signals to the brain and lowering pain levels.

EASE-AMPUTEES/2535129/

A new study shows that the most common medications and Boniva®) used

for treatment of hyperparathyroidism, a condition that causes bone loss, may actually increase risk of fractures.

The study of 6,000 people with hyperparathyroidism found that those treated with bisphosphonates suffered

hip fracture at the rate of 86 per 1000. Those who had para-thyroid surgery reported 20 fractures per 1000, and those

who were not treated at all recorded 56 fractures per 1000.

?SC=DWHP

NEWBONE-LOSS MEDICATIONSmay be worse than no treatment

N E U R O M O D U L A T I O NT R E AT ME N T forCRPS PA IN