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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 3 (month 12 of 12)
Awards & highlights

Study 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
  • Opioid Addiction
  • Chronic Lower Back Pain

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brace fitting and assessment
Pain and opioid reduction

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
13 Previous Clinical Trials
3,751 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025