Chronic Lower Back PainNCT02241824
Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
A study testing In-elastic lumbar brace and Elastic abdominal binder in people with Chronic Lower Back Pain and Chronic Opioid Use, run by Geoffrey C. Garth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 72 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Lower Back Pain, Chronic Opioid Use
- What is being tested?
- In-elastic lumbar brace and Elastic abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 72 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Long Beach VA
Long Beach, California, 90822
Sophia Chun, MD, 562-826-5701, sophia.chun@va.gov
About this study
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.
Read more
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.
Read the detailed description
Background and Significance
Low back pain (LBP) is a common problem in our society with potential for significant morbidity and mortality. One of the treatments for LBP, opioid therapy, has been increasingly utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The long term use of opioids carries its own risk for adverse events and risk of addiction.3 Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid therapy, our attention needs to be drawn to find more affordable alternatives.
Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid use in the chronic low back pain population. The specific aims of this project are to perform a pilot study to assess the feasibility of this project and plan for a larger randomized controlled trial. Additional long-term goals of this study are to assess the effect of an inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in opioid use and subsequent control or reduction of pain. Secondary endpoints will note improvement in functional outcomes and other quality of life measures. The findings of this preliminary study conducted at the VA facility will provide data to perform a large multi-center randomized controlled trial and prepare for a NIH proposal to study other benefits of inelastic lumbar bracing.
(3) Work Accomplished
(a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions Following Pilot Studies: Sponsored new study
(4) Work Proposed This trial will be a prospective randomized three armed trial of an in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid medications with follow-up monitoring up to 12 months.
- Conditions
- Chronic Lower Back Pain, Chronic Opioid Use
- Being tested
- In-elastic lumbar brace, Elastic abdominal binder
- Keywords
- Lumbar Orthosis, Lumbar brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-elastic lumbar braceDevice
Elastic abdominal binderDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: In-elastic lumbar brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Visit 3 (month 12 of 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geoffrey C. Garth
- Sponsor type
- University, hospital or other
- Collaborators
- VA Long Beach Healthcare System
- Responsible party
- Sponsor-investigator, Geoffrey C. Garth, Aspen Medical Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241824
- Sponsor's protocol ID
- MIRB# 1273
- Status last verified
- Jul 2015
- First submitted
- 26 May 2014
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
- ClinicalTrials.gov ID
- NCT02241824
- Acronym / sponsor ID
- MIRB# 1273
- Conditions
- Chronic Lower Back Pain, Chronic Opioid Use
- Keywords
- Lumbar Orthosis, Lumbar brace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Geoffrey C. GarthUniversity, hospital or other
- Collaborators
- VA Long Beach Healthcare System
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Significance
Low back pain (LBP) is a common problem in our society with potential for significant morbidity and mortality. One of the treatments for LBP, opioid therapy, has been increasingly utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The long term use of opioids carries its own risk for adverse events and risk of addiction.3 Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid therapy, our attention needs to be drawn to find more affordable alternatives.
Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid use in the chronic low back pain population. The specific aims of this project are to perform a pilot study to assess the feasibility of this project and plan for a larger randomized controlled trial. Additional long-term goals of this study are to assess the effect of an inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in opioid use and subsequent control or reduction of pain. Secondary endpoints will note improvement in functional outcomes and other quality of life measures. The findings of this preliminary study conducted at the VA facility will provide data to perform a large multi-center randomized controlled trial and prepare for a NIH proposal to study other benefits of inelastic lumbar bracing.
(3) Work Accomplished
(a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions Following Pilot Studies: Sponsored new study
(4) Work Proposed This trial will be a prospective randomized three armed trial of an in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid medications with follow-up monitoring up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elastic abdominal binder | Active comparator | Device: Elastic abdominal binderTo evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an 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 | Device: In-elastic lumbar braceTo evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an in-elastic lumbar brace. |
Who may qualify
- Ages
- 20 to 72 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must satisfy diagnostic criteria for lumbar back pain
- Evidence of lumbar back pain base upon one or more of the following:
- Men or women age greater than or equal to 20 years
- Fluency in English
Key exclusion criteria (7 listed)
- Treatment risk factors including one or more of the following:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-elastic lumbar brace | Device | In-elastic lumbar brace |
| Elastic abdominal binder | Device | Elastic abdominal binder |
Primary outcome
Brace fitting and assessment
Time frame: Initial visit (month 1 of 12)
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.
Pain and opioid reduction
Time frame: Visit 2: (month 3 of 12)
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.
Pain and opioid reduction
Time frame: Visit 3 (month 12 of 12)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-elastic lumbar brace and Elastic abdominal binder in people with Chronic Lower Back Pain and Chronic Opioid Use, run by Geoffrey C. Garth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Y Chang, MD ((714) 598-1745, eric.chang6@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brace fitting and assessment (time frame: Initial visit (month 1 of 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.