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Orthosis

In-elastic lumbar brace for Opioid Addiction

N/A
Waitlist Available
Research Sponsored by Geoffrey C. Garth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2: (month 3 of 12)
Awards & highlights
No Placebo-Only Group

Summary

Rationale * Statement of the Problem. Low back pain is a significant societal problem in the United States, affecting approximately one-fourth of all Americans at any given time. Non-pharmacological therapies have not been well studied although preliminary evidence shows the utilization of bracing may be beneficial in reducing pain and medication usage. * Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic lumbar brace may decrease opioid use in chronic low back pain patients on a stable opioid regimen. The investigators propose to conduct a randomized controlled study to test our hypothesis. * Specific Objectives. AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace, elastic abdominal binder (standard care), and no brace (control). AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life, and functional capacity. Long Term aims: To decrease patient's chronic pain level, improve overall daily function, decrease overall opioid intake and improve quality of life.

Eligible Conditions
  • Chronic Lower Back Pain
  • Opioid Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2: (month 3 of 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2: (month 3 of 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brace fitting and assessment
Pain and opioid reduction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: In-elastic lumbar braceExperimental Treatment1 Intervention
To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an in-elastic lumbar brace.
Group II: Elastic abdominal binderActive Control1 Intervention
To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an elastic abdominal binder.
Group III: No braceActive Control1 Intervention
To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen with no brace (control).

Find a Location

Who is running the clinical trial?

Geoffrey C. GarthLead Sponsor
VA Long Beach Healthcare SystemFED
15 Previous Clinical Trials
4,459 Total Patients Enrolled
~3 spots leftby Nov 2025