Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention

NCT02241824 | Unknown DMC

• 1 other identifier: MIRB# 1273
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Lumbar Orthosis; Lumbar brace

Outcome Measures

Primary Outcomes (3)

• Brace fitting and assessment

  Visit 1: Screening \& randomization Study parameters and informed consent will be explained and given to potential participants. If interested, study staff will confirm eligibility and randomize the patient into a group. Patient demographics, medical history and surgical history will be obtained as well as basic vitals. A study team member will then perform the physical function exam, administer the pain assessment, and record current opioid use. Patients will then be fitted for a brace (for those with a brace) and instructed to wear the brace all day, every day except when sleeping or showering. Patients will then be given the packet of quality of life questionnaires and ODI surveys and given ample time to fill them out. Before leaving, patients will schedule the next two phone call checkups and the 3 month visit.

  Initial visit (month 1 of 12)

• Pain and opioid reduction

  Visit 2 (3 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion, degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). Prior to leaving the patient will schedule monthly telephone contacts for the next 8 months as well as their last physical visit at the 12 month time point.

  Visit 2: (month 3 of 12)

• Pain and opioid reduction

  Visit 3 (12 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion (active and passive), degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). All patients will be notified that they can keep their brace, if they were given one for the study and that they have completed the study.

  Visit 3 (month 12 of 12)

Study Arms (3)

Elastic abdominal binder

ACTIVE COMPARATOR

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

Device: Elastic abdominal binder

No brace

NO INTERVENTION

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

In-elastic lumbar brace

EXPERIMENTAL

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.

Device: In-elastic lumbar brace

Interventions

In-elastic lumbar brace DEVICE

In-elastic lumbar brace

Elastic abdominal binder DEVICE

Elastic abdominal binder

Eligibility Criteria

• Age: 20 Years - 72 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Geoffrey C. Garth: lead
• VA Long Beach Healthcare System: collaborator

Study Sites (1)

Long Beach VA

Long Beach, California, 90822, United States

RECRUITING

Central Study Contacts

Eric Y Chang, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: September 16, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

US (1)