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Lumbar Back Bracing Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484403
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Aspen Medical Products
Information provided by (Responsible Party):
Thiru Annaswamy, Dallas VA Medical Center

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE March 30, 2018
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE December 14, 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • Pain Diary [ Time Frame: Change between baseline and each week for 6 weeks ]
    Patients rate their weekly pain on a scale from 0-10
  • Pain Disability Questionnaire [ Time Frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months) ]
    Measures how pain affects the patients lifestyle
  • PROMIS Instrument Questionnaire [ Time Frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months) ]
    Measure of patients pain
  • European Qualify of Life (EQ-5D) Questionnaire [ Time Frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months) ]
    Measures quality of life for pre- and post comparisons
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Back Bracing Study
Official Title  ICMJE Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Lumbar Spondylosis
  • Low Back Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Control Group
    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.
    Intervention: Behavioral: Back school
  • Experimental: Treatment Group
    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.
    Interventions:
    • Other: Lumbar back brace
    • Behavioral: Back school
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 29, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03484403
Other Study ID Numbers  ICMJE 15-088
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Thiru Annaswamy, Dallas VA Medical Center
Study Sponsor  ICMJE Dallas VA Medical Center
Collaborators  ICMJE Aspen Medical Products
Investigators  ICMJE Not Provided
PRS Account Dallas VA Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP