Back to resultsComparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain (COMPETE)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care (UC)
Early Physical Therapy (PT)
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring back pain, primary care, physical therapy
Eligibility Criteria
Inclusion Criteria -
- Military personnel on active duty and eligible for healthcare at a military treatment facility
- A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
- Duration of current episode of low back pain < 90 days
- Age 18 - 60 years (or emancipated minors on active duty)
- Available for the following 4 weeks to complete a regimen of treatment
Exclusion Criteria:
- Oswestry Disability Index < 20%
- History of receiving any medical care for this episode of low back pain within the last 3 months
- Prior surgery to the thoraco-lumbar spine or pelvis
- This episode of back pain is due to a traumatic fracture
- Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
- Any "red flags" that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease.
- Current episode occurred because of a motor vehicle accident
- Currently pregnant (or history of pregnancy in the previous 6 months)
Sites / Locations
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual Care (UC)
Early Physical Therapy (PT)
Arm Description
The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.
All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.
Outcomes
Primary Outcome Measures
Modified Oswestry Disability Index
The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.
Secondary Outcome Measures
Numeric Pain Rating Scale (NPRS)
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference of two points among patients with acute LBP receiving physical therapy.
Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
The GRC is a 15-point scale that asks the patient to rate the degree of change in his or her condition from the beginning of treatment to the present. The mid-point of the scale is no change (0). Ratings from -1 to -7 represent varying degrees of a worsening of the patient's condition, while rating from +1 to +7 represent varying degrees of improvement. A score of 3 or higher is considered clinically meaningful change.
Full Information
NCT ID
NCT01556581
First Posted
March 14, 2012
Last Updated
June 29, 2020
Sponsor
Madigan Army Medical Center
Collaborators
U.S. Army Medical Research and Development Command, William Beaumont Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01556581
Brief Title
Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
Acronym
COMPETE
Official Title
Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madigan Army Medical Center
Collaborators
U.S. Army Medical Research and Development Command, William Beaumont Army Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.
Detailed Description
The specific aims of this study are the following:
Compare the effectiveness of two primary care management strategies for patients with a recent onset of combat-related LBP. We hypothesize early physical therapy access for these Soldiers will result in greater improvements in function and quality of life over 1 year as compared to a stepped care strategy.
Compare the subsequent healthcare utilization associated with two management strategies for patients with a recent onset combat-related LBP. We hypothesize early physical therapy access will result in decreased healthcare utilization over 1 year as compared to a stepped care strategy.
Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
back pain, primary care, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (UC)
Arm Type
Active Comparator
Arm Description
The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.
Arm Title
Early Physical Therapy (PT)
Arm Type
Active Comparator
Arm Description
All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.
Intervention Type
Procedure
Intervention Name(s)
Usual Care (UC)
Intervention Description
Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress.
Intervention Type
Procedure
Intervention Name(s)
Early Physical Therapy (PT)
Intervention Description
Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms).
Primary Outcome Measure Information:
Title
Modified Oswestry Disability Index
Description
The Modified Oswestry Disability Questionnaire (OSW) is a 10-item condition-specific measure of functional status (pain and disability) for patients with low back pain (LBP). Each question has 6 possible answers (0 = worse, 5 = best). The raw score is doubled to provide a percent score from 0 to 100%; with 0 equaling no disability and 100% equalling the worst possible outcome. It measures pain-related disability. We used the modified version that replaces the sex life item with an employment/ homemaking item due to poor compliance with the former. The OSW is widely used in research on non-operative management of patients with LBP, with high levels of test-retest reliability among stable patients (ICC = 0.90), good construct validity, and responsiveness to change for patients with acute LBP. It has a minimum clinically important difference of 6 points.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability. Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference of two points among patients with acute LBP receiving physical therapy.
Time Frame
12 months
Title
Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
Description
The GRC is a 15-point scale that asks the patient to rate the degree of change in his or her condition from the beginning of treatment to the present. The mid-point of the scale is no change (0). Ratings from -1 to -7 represent varying degrees of a worsening of the patient's condition, while rating from +1 to +7 represent varying degrees of improvement. A score of 3 or higher is considered clinically meaningful change.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria -
Military personnel on active duty and eligible for healthcare at a military treatment facility
A primary complaint of low back pain defined as symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into the leg(s), which, in the opinion of the provider, are originating from tissues of the lumbar region.
Duration of current episode of low back pain < 90 days
Age 18 - 60 years (or emancipated minors on active duty)
Available for the following 4 weeks to complete a regimen of treatment
Exclusion Criteria:
Oswestry Disability Index < 20%
History of receiving any medical care for this episode of low back pain within the last 3 months
Prior surgery to the thoraco-lumbar spine or pelvis
This episode of back pain is due to a traumatic fracture
Pending a medical or physical evaluation board or discharge process, pending any litigation related to the condition, or planning on getting out of the military within the next 9 months.
Any "red flags" that would indicate a potentially serious condition or other significant disease process. These could include but not limited to cauda equina syndrome, large or rapidly progressing neurological deficit, fracture, cancer, ankylosing spondylitis, or other systemic disease.
Current episode occurred because of a motor vehicle accident
Currently pregnant (or history of pregnancy in the previous 6 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fritz, PT, PhD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
Facility Information:
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Any data sharing must go through a Data Sharing Agreement through the Defense Health Agency
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
Any data sharing must go through a Data Sharing Agreement through the Defense Health Agency
IPD Sharing URL
https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application
Citations:
PubMed Identifier
22614792
Citation
Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.
Results Reference
background
PubMed Identifier
23337426
Citation
Fritz JM, Brennan GP, Hunter SJ, Magel JS. Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization. Arch Phys Med Rehabil. 2013 May;94(5):808-16. doi: 10.1016/j.apmr.2013.01.008. Epub 2013 Jan 18.
Results Reference
background
PubMed Identifier
18628714
Citation
Fritz JM, Cleland JA, Speckman M, Brennan GP, Hunter SJ. Physical therapy for acute low back pain: associations with subsequent healthcare costs. Spine (Phila Pa 1976). 2008 Jul 15;33(16):1800-5. doi: 10.1097/BRS.0b013e31817bd853.
Results Reference
background
PubMed Identifier
29489568
Citation
Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
Results Reference
derived
PubMed Identifier
26399603
Citation
Rhon D, Fritz J. COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:423. doi: 10.1186/s13063-015-0959-8.
Results Reference
derived
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Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
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