Recruiting

Lumbar Orthosis

Sponsor:

Geoffrey C. Garth

Code:

NCT02241824

Conditions

Chronic Lower Back Pain

Chronic Opioid Use

Eligibility Criteria

Sex: Male

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

In-elastic lumbar brace

Elastic abdominal binder

Study Details

Brief 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.

Conditions

Chronic Lower Back Pain

Chronic Opioid Use

Study ID

NCT02241824

Start date

Jan, 2015

Status verified date

Jul, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must satisfy diagnostic criteria for lumbar back pain
  • Evidence of lumbar back pain base upon one or more of the following:

  • Lumbar back pain episodes lasting greater than 3 months
  • Has received treatment for recurring nonspecific low back pain
  • Treatment with 3-6 months of stable opioid use.
  • Men or women age greater than or equal to 20 years
  • Fluency in English

Exclusion Criteria:

  • Treatment risk factors including one or more of the following:

  • Unstable or symptomatic cardiac complaints
  • Unstable or symptomatic respiratory complaints
  • Unable to reliably comprehend the protocol or reliably record data
  • Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
  • Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
  • No significant alcohol use (7 or fewer drinks per week).

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Elastic abdominal binder

To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an elastic abdominal binder.

no intervention: No brace

To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen with no brace (control).

experimental: In-elastic lumbar brace

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.

Interventions

In-elastic lumbar brace

Elastic abdominal binder

Primary outcome measure

  • Brace fitting and assessment [ Time Frame: Initial visit (month 1 of 12) ]
  • Pain and opioid reduction [ Time Frame: Visit 2: (month 3 of 12) ]
  • Pain and opioid reduction [ Time Frame: Visit 3 (month 12 of 12) ]

Central Contacts and Locations

Central contacts

Eric Y Chang, MD

(714) 598-1745eric.chang6@va.gov

Locations

Long Beach VA

Recruiting

Long Beach, California, United States, 90822

Contacts

Sophia Chun, MD

562-826-5701sophia.chun@va.gov

More Information

Sponsor

Geoffrey C. Garth

Last update posted

Jul 9, 2015

Last verified

Jul, 2015

Keywords

  • Lumbar Orthosis
  • Lumbar brace

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Geoffrey C. Garth on 2015-07-09.