FEATURE

Prospective Study of a Lumbar Back Brace In an Interventional Pain Practice

Richard Rosenthal, MD Medical Director Nexus Pain Care Provo, UT Shawn Spencer, BS Research assistant Nexus Pain Care Chicago, IL

Back bracing may be a cost-effective means of providing immediate relief from low back pain, and act as an effective bridge to other interventions.

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Low back pain (LBP) is a frequent problem in industrialized countries and is the second most common reason for visits to physicians.1,2 Approximately 70% to 85% of adults have suffered or currently suffer from LBP, and its prevalence continues to rise.1 In any given year, 15% to 45% of the population will experience an episode of LBP, with the incidence increasing in older adults up to age 65.1

Although the duration of most LBP episodes is usually brief (1-2 weeks), recurrent symptoms are common.3 Among patients who report recurring problems, symptoms often resolve spontaneously, many times without any intervention. However, many patients suffer from prolonged symptoms that do not resolve quickly. Some authors have reported that between 10% and 33% of patients report persistent pain after 1 year.3 Within this group, recovery is often protracted, and their treatment accounts for a majority of the spending on the problem. This segment of patients makes

up a large portion of individuals on work disability. Lumbar Supports Lumbar supports have been used in the workplace to treat LBP and to prevent strains. They also are used in primary care to reduce pain and improve mobility.1 Although interventional pain physicians routinely see patients with LBP, lumbar supports are not a common part of most of their treatment plans. This may be due to the widely held notion that a lumbar support might result in atrophy of already weakened core muscles. Research

Practical Pain Management | July/August 2011

Prospective Study of a Lumbar Back Brace In an Interventional Pain Practice

Table 1. Exclusion Criteria

Lumbar spinal stenosis Suspected SI joint pain Lumbar radicular pain Work-related injuries Current unresolved litigation Psychological disorder determined by function less than 5 on scale from 0 to 10 or ability to cope with pain less than 5 on scale of 0 to 10 Suspected opiate abuse History of previous operation on lumbar spine Serious cardiopulmonary conditions History of spinal instability Medical cause for LBP (tumor, infection, metabolic diseases) Pregnancy
LBP, low back pain; SI, sacroiliac.

benefit for several weeks. For example, a physician may perform one or two medial branch nerve blocks prior to proceeding with radiofrequency (RF) nerve ablation. However, the patient may not experience the full benefit of the RF procedure for up to 4 weeks. Opiates are an option for providing relief during this period, but they come with certain risks, and many patients are already using them with unsatisfactory outcomes or with side effects. For this purpose, we undertook a study to determine if back bracing was a reliable means of providing immediate relief from LBP. Prospective Study This study was conducted to confirm the results of the trial mentioned above and to determine if bracing could provide a reliable means to deliver immediate relief to patients with severe and chronic pain. We hoped to find a nonpharmacologic treatment option that could be offered during the initial evaluation and would improve function while reducing disability levels. Patients with lumbar pain above the L5 level were asked to participate in the study. Exclusion criteria are listed in Table 1. Nineteen consecutive patients participated in the study (8 men and 11 women) with an average age of 50.3 years (range, 22-74). The average duration of their symptoms was 8.89 years (range, 0.3-31 years). Upon enrolling in the study, patients were asked to rate their pain using a visual analog scale (VAS) and to fill out the Roland Morris Disability Questionnaire (RMDQ) before receiving a brace. Patients were then fitted with a brace and instructed to wear it when their pain was severe or when they planned on performing an activity that normally caused an increase in pain.
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does not definitively support this position.4-6 One study even reported an increase in muscle strength after the brace was worn for 6 weeks.6 The authors acknowledged that the brace itself likely did not affect muscle fiber size, but rather that the patients reduced pain allowed greater mobility, thereby encouraging increased strength and flexibility. Previous studies demonstrate that use of a lumbar support can be a viable and helpful method of improving back pain symptoms. One recent multicenter, randomized controlled trial measured three outcome measures for patients wearing an elastic lumbar support: pain level, function, and medication use. Patients in the treatment group showed improvement in

all three areas, and the authors concluded that back bracing is an effective treatment option for LBP.2 Bridge to Pain Relief Most patients seeking treatment from a pain management specialist have experienced pain for upwards of 1 year. By the time they present to a pain clinic, their pain has generally caused them significant distress, and they are seeking rapid intervention to alleviate their symptoms. However, fully understanding each patients unique situation with diagnostic tools such as injections and planning the appropriate course of treatment to produce long-lasting, definitive results can take several weeks. Even after treatment is performed, patients may not

July/August 2011 | Practical Pain Management

Prospective Study of a Lumbar Back Brace In an Interventional Pain Practice

Table 2. Pain Scores Initial Pain

8 5 10 6 5 6 8 7 7 5 7 7 7 8 10 7.5 6.5 10 6

Patient

Pain Directly After Orthosis

2 4 6 5 3 3 6 2 2 4 4 4 4 5 9 5 3 4 5

Overall Pain 5 Days After Use

5 3 4 3 5 4 5 1 1 3 5 4 7 6 6 4 4 4 4

Percent Reduction of Pain, %

25 50 40 50 0 30 30 80 75 40 25 33 0 25 40 33 40 30 50

lumbar support with a semi-rigid lumbar panel while still allowing patients the mobility necessary to maintain core strength. Results Patients reported wearing the device for an average of 2.28 hours per day (range, 0.6-5.2 hours). Patients average VAS pain score dropped by 41.2% (from 7.16-4.21) immediately upon donning the device and dropped slightly further (to 4.11) by the end of the study period. The average RMDQ score dropped by 40% (from 16.3 to 9.79). The detailed results of the two main areas of study are listed in Tables 2 to 4, with the overall results listed in Table 5. In addition to the positive results from the two main areas of study, patient surveys revealed that 95% (18 of 19) of the patients were either satisfied or very satisfied with the device (42% very satisfied, 53% satisfied). One patient was dissatisfied. In addition, 95% said that they would recommend the device to a friend with back pain. Discussion The BackJack back brace is a uniquely designed device for use by patients with both acute and chronic pain. It allows reasonable flexibility but does restrict trunk motion for flexionextension and lateral bending movements, which is one of the ways that these devices may work to prevent LBP.7 Although the scope of this study did not include investigating the mechanism by which this device relieves pain, we suspect that a number of features factor into its effectiveness. The main mechanism of control is compression delivered by the cinching system. This action may increase intracavitary pressure and provide some additional stability to the spine.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
a

Based on a 0-10 visual analog scale.

Immediately after donning the brace in the clinic, patients were asked to rate their pain again on the VAS. After 5 days, the patients again completed the RMDQ and were asked to again rate their pain on the VAS scale. In addition to tracking VAS pain scores and RMDQ results, patients also were asked to track how much time they spent wearing the device. In addition, we asked them to rate their overall satisfaction (very satisfied, satisfied, dissatisfied, provided no value)
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with the device and whether or not they would recommend it to a friend with back pain. Support Device The device we selected to use (BackJack, Cropper Medical) has a semi-rigid lumbar panel with soft, nonelastic panels around the front and sides. Patients use a cinching mechanism to draw the lumbar panel against the spine. This device was selected because it provides firm

Practical Pain Management | July/August 2011

Prospective Study of a Lumbar Back Brace In an Interventional Pain Practice

Table 3. Functional Disability Scores RMDQ Day 1 (24 max) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

22 11 19 15 19 13 17 9 15 15 11 15 16 20 20 20 18 23 12

RMDQ Day 5 (24 max)

8 3 7 7 19 11 12 5 7 11 11 12 14 9 7 8 7 21 7

Percent Reduction of RMDQ, %

64 73 63 53 0 15 29 44 53 27 0 20 13 55 65 60 61 9 42

Patients can receive some level of relief during their first appointment and can continue to use the device as needed throughout the course of their treatment. Patients can evaluate the devices efficacy in the clinic and decide if it provides enough benefit to warrant the expense. The second major advantage we see is that patients have access to a nonpharmacologic tool to deal with their back pain at home. Most patients experience occasional flare-ups. In some patients, this can be a regular occurrence. Having access to a nonnarcotic alternative that diminishes their pain makes them less likely to require treatment for those temporary spikes in pain levels. Limitations of Study Our study group was relatively small and was not randomized. Furthermore, the duration of the study was relatively short. The study was not intended to provide definitive proof of the efficacy of back bracing, but rather to assess the usefulness of bracing when dealing with the complex challenges and needs of interventional pain patients. Further study would be necessary to establish longterm benefits and effects on total cost of care. To our knowledge, no previous study has specifically looked at this population of patients and their response to application of a lumbar orthosis. Summary Interventional pain physicians are uniquely tasked with finding ways to provide relief to a challenging group of patients who have suffered with severe, long-term pain. We found that the use of a back brace provided an immediate 41% reduction in pain on the initial visit. After 5 days, patients reported a 40% improvement in function and a 43% reduction in pain.
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RMDQ, Roland Morris Disability Questionnaire.

The compression and posterior support also provides a static stretch of the erector spinae muscles, which has been shown to be an effective means of alleviating myogenic pain.6,8-10 Finally, pain relief provided by the devise could be the result of directed force against the lumbar spine, which could limit motion in the facet joints. More research is needed to elucidate

the means by which this device relieves pain. Based on the results of this study, we see two main benefits to including back bracing as part of the treatment protocol in an interventional pain clinic. The first is the immediacy of the results. We observed a significant reduction in pain levels during the first application of the device.

July/August 2011 | Practical Pain Management

Prospective Study of a Lumbar Back Brace In an Interventional Pain Practice

Table 4. Patient Demographics

Gender Average Age Average Duration of Symptoms Male: 8 Female: 11 50.32 years 8.89 years

3 years and was recently accepted into medical school. He plans to matriculate in the fall. Dr. Rosenthal has disclosed that this study was supported by a research grant from Cropper Medical, makers of the BlackJack device. Mr. Spencer has no financial information to disclose.

Table 5. Overall Resultsa

Average initial pain Average pain immediately after use of brace Average immediate reduction of pain Average pain after 5 days of use of orthosis Average reduction of pain after 5 days of use Average initial RMDQ score Average RMDQ score after brace Average reduction of RMDQ Average hours of use
a

7.16 4.21 41.2% 4.11 42.6% 16.32 9.79 40% 2.28

References 1. van Duijvenbode I, Jellema P, van Poppel M, van Tulder MW. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev. 2010;(2):CD001823. 2. Calmels P, Queneau P, Hamonet C, et al. Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study. Spine. 2009;34(3):215-220. 3. Coste J, Delecoeuillerie G, Cohen de Lara A, Le Parc JM, Paolaggi JB. Clinical course and prognostic factors in acute low back pain: an inception cohort study in primary care practice. BMJ. 1994;308:577-580. 4. von Korff M, Saunders K. The course of back pain in primary care. Spine. 1996;21(24):2833-2837. 5. Fayolle-Minon I, Calmels P. Effect of wearing a lumbar orthosis on trunk muscles: study of the muscle strength after 21 days of use on healthy subject. Joint Bone Spine. 2008;75(1):58-63. 6. Penrose K, Chook K, Stump J. Acute and chronic effects of pneumatic lumbar support on muscular strength, flexibility, and functional impairment index. Sports Med Train Rehabil. 1991;2(2):121-129. 7. van Poppel MN, de Looze MP, Koes BW, Smid T, Bouter LM. Mechanisms of action of lumbar supports: a systematic review. Spine. 2000;25(16):2103-2113. 8. Allman F. Exercise in sports medicine. In: Basmajian J, ed. Therapeutic Exercise. 3rd ed. Baltimore, MD: Williams & Wilkins; 1978. 9. Beaulieu J. Developing a stretching program. Phys Sportsmed. 1981;9:59-69. 10. Berger R. Applied Exercise Physiology. Philadelphia, PA: Lea & Febiger; 1952:116-117.

Overall improvement of both scores from day 1 to day 5. RMDQ, Roland Morris Disability Questionnaire

Nearly all of the patients were pleased with the device, and none reported any side effects of discomfort arising from use of the brace. Given these results, we recommend use of back bracing as a means of providing symptomatic relief for patients with chronic LBP. Authors Bios: Richard M. Rosenthal, MD, is medical director of the Utah Center for Pain Management and Research. Dr. Rosenthal has practiced pain management for 20 years, and has been committed to teaching interventional pain management to physicians throughout the United States
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and Europe. Dr. Rosenthal has directed Nexus Pain Care in performing extensive clinical research and incorporated an academic dimension into his private clinic: a 1- year fellowship program to help fully trained doctors hone their skills in the specialized procedures done in the clinic. He has had the privilege of instructing for the International Spinal Injection Society for the past 10 years. He is committed to teaching correct techniques for the performance of spinal injections. Shawn Spencer graduated from Brigham Young University with a bachelors degree in physiology and developmental biology. He has been a research assistant to Dr. Rosenthal for the past

Practical Pain Management | July/August 2011