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

NCT03484403 | Completed Results

• 1 other identifier: 15-088
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Degenerative Disc Disease; Lumbar Spondylosis; Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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).

• 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)

• 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)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.

Behavioral: Back school

Treatment Group

EXPERIMENTAL

Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.

Other: Lumbar back brace; Behavioral: Back school

Interventions

Lumbar back brace OTHER

A brace that supports the lumbar region of the spine.

Treatment Group

Back school BEHAVIORAL

Back school consists of patient education physical therapy exercise instruction.

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lumbar radiculopathy
• Neurogenic claudication
• Spondylolisthesis with instability
• Previous lumbar spine surgery
• Recent (\<1 year) brace use or physical therapy program
• No active psychiatric illness

Sponsors & Collaborators

• Dallas VA Medical Center: lead
• Aspen Medical Products: collaborator

Related Publications (8)

• 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.

  PMID: 25387146 BACKGROUND

• 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.

  PMID: 20823783 BACKGROUND

• 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.

  PMID: 20452305 BACKGROUND

• 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.

  PMID: 18425875 BACKGROUND

• 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.

  PMID: 23904227 BACKGROUND

• 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.

  PMID: 19179915 BACKGROUND

• 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.

  PMID: 18303469 BACKGROUND

• Annaswamy TM, Cunniff KJ, Kroll M, Yap L, Hasley M, Lin CK, Petrasic J. Lumbar Bracing for Chronic Low Back Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2021 Aug 1;100(8):742-749. doi: 10.1097/PHM.0000000000001743.

  PMID: 33789322 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylosis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Thiru Annaswamy
• Organization: Dallas VA Medical Center

thiru.annaswamy@va.gov

214-857-0273

Study Officials

• Thiru Annaswamy, M.D.

  Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PM&R, Principal Investigator, Staff Physician

Model Details: This is a prospective, randomized controlled trial. Blinding of the subjects is not possible because a back brace is a visibly obvious intervention. In addition, since we are evaluating the adherence of back brace wear, blinding of the investigator is also not possible. Therefore, this study will be an unblinded RCT.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: December 14, 2015
• Primary Completion: September 10, 2019
• Study Completion: September 30, 2019
• Last Updated: January 8, 2024
• Results First Posted: January 8, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share