Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease

Low Back Pain Clinical Trial

Official title:

Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484403
• Other study ID #: 15-088
• Status: Completed
• Phase: N/A
• Start date: December 14, 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2023
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or neurogenic claudication.

The secondary objectives of the study are to evaluate if a back brace provides any additive benefit to usual care consisting of exercise and patient education in patients with CLBP due to degenerative disc disease.

Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and patient-reported functional measures in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy.

Hypothesis 1. Back brace in addition to usual care will provide statistically significant improvement in pain and functional measures compared to usual care alone.

Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will demonstrate clinically acceptable rates of adherence to brace wear instructions.

Description:

Physiatrists use back braces (lumbar support, back corset, semi-rigid brace, and lumbar orthotic) for symptomatic management of patients' chronic low back pain (CLBP) despite very poor evidence supporting their use in the few published studies that have examined them. Evidence supporting back braces in other populations, such as pregnant women, and patients with sub-acute or acute low back pain, is better established. However, the benefits of back braces in the CLBP population are very unclear.

A Cochrane review on the role of lumbar supports in treating chronic LBP revealed that limited evidence was available, which led to the conclusion that, "it remains unclear whether lumbar supports are more effective than no or other interventions for treating low-back pain." The research emphasized the need for high quality randomized trials evaluating the effectiveness of back braces, and also recommended that compliance of brace wear be monitored.

The mechanism by which back braces might help patients with CLBP is also unclear. The semi-rigid design of the commonly used back brace does not mechanically limit movement enough to suggest that movement limitation is the mechanism by which back braces provide relief. However, some studies have suggested that back braces help patients with CLBP by providing postural support or a kinesthetic reminder of their posture. Using posturography, Munoz et al., studied the forces applied by lumbar bracing and concluded that back braces seem to help by improving the quality of balance strategy used by the patient. Another mechanism by which back braces are believed to help patients is by providing warmth underneath the brace.

There is poor published information regarding adherence to instructions (compliance) about the use of back braces. Based on the investigators' anecdotal clinical experience, adherence rates vary widely among patients who are prescribed back braces, ranging from non-use to constant use around the clock. Poor adherence to instructions can be a significant factor resulting in inconclusive evidence supporting the role of back brace in patients with CLBP. A recent study showed that a strong predictor for consistent adherence to back brace usage was a positive attitude towards it. In this study, positive attitude towards the back brace explained 41% of the variance in outcomes. In addition, investigators found that perceived benefit from the brace outweighed any subjective discomfort.

Back braces have been used as adjunctive therapy in addition to other conservative care options. A recent study evaluated the cumulative effect of bracing to exercise and found that bracing helps to increase trunk stiffness and augments muscle contractions, which may remind the patients to better comply with exercise instructions. This suggested a potential synergistic effect of bracing and exercise in the management of patients with CLBP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 30, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of lumbar degenerative disc disease or joint disease

• Low back pain > 6 weeks

• Uncomplicated low back pain without symptoms of pain radiating below the knee

Exclusion Criteria:

• Lumbar radiculopathy

• Neurogenic claudication

• Spondylolisthesis with instability

• Previous lumbar spine surgery

• Recent (<1 year) brace use or physical therapy program

• No active psychiatric illness

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain
• Lumbar Spondylosis
• Spinal Diseases
• Spondylosis

Intervention

Other:
• Lumbar back brace
A brace that supports the lumbar region of the spine.

Behavioral:
• Back school
Back school consists of patient education physical therapy exercise instruction.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dallas VA Medical Center	Aspen Medical Products

References & Publications (7)

Calmels P, Queneau P, Hamonet C, Le Pen C, Maurel F, Lerouvreur C, Thoumie P. Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):215-20. doi: 10.1097/BRS.0b013e31819577dc. — View Citation

Munoz F, Salmochi JF, Faouen P, Rougier P. Low back pain sufferers: is standing postural balance facilitated by a lordotic lumbar brace? Orthop Traumatol Surg Res. 2010 Jun;96(4):362-6. doi: 10.1016/j.otsr.2010.01.003. Epub 2010 May 7. — View Citation

O'Keeffe M, Nolan D, O'Sullivan P, Dankaerts W, Fersum K, O'Sullivan K. Re: Aleksiev AR. Ten-year follow-up of strengthening versus flexibility exercises with or without abdominal bracing in recurrent low back pain. Spine (Phila Pa 1976). 2014 Nov 15;39(24):E1495-7. doi: 10.1097/BRS.0000000000000620. No abstract available. — View Citation

Pennick V, Liddle SD. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2013 Aug 1;(8):CD001139. doi: 10.1002/14651858.CD001139.pub3. — View Citation

Podichetty VK, Varley ES. Re: Oleske D M, Lavender S A, Andersson G B, et al. Are back supports plus education more effective than education alone in promoting recovery from low back pain? Results from a randomized clinical trial. Spine 2007;32:2050-7. Spine (Phila Pa 1976). 2008 Feb 1;33(3):349-50. doi: 10.1097/BRS.0b013e31816244db. No abstract available. — View Citation

Roelofs PD, Bierma-Zeinstra SM, van Poppel MN, van Mechelen W, Koes BW, van Tulder MW. Cost-effectiveness of lumbar supports for home care workers with recurrent low back pain: an economic evaluation alongside a randomized-controlled trial. Spine (Phila Pa 1976). 2010 Dec 15;35(26):E1619-26. doi: 10.1097/BRS.0b013e3181cf7244. — View Citation

van Duijvenbode IC, Jellema P, van Poppel MN, van Tulder MW. Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD001823. doi: 10.1002/14651858.CD001823.pub3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Diary	Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes.; Average weekly pain scores were compared from baseline to 6 week mark.	Change between baseline and each week for 6 weeks
Primary	Pain Disability Questionnaire	Measures how pain affects the patients lifestyle and participation in activities.; Ranges from 0-150. Higher values indicate worse outcome.	These assessments were made at baseline (T0), 6 wks (T1), 12 wks (T2), and 6 mos (T3). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).
Primary	PROMIS Instrument Questionnaire	Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112	Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
Primary	European Qualify of Life (EQ-5D) Questionnaire	Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10	Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)