Low Back Pain Clinical Trial
Official title:
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
Verified date | April 2023 |
Source | Dallas VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dallas VA Medical Center | Aspen Medical Products |
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
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) |
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