Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain (COMPETE)

Madigan Army Medical Center

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Early Physical Therapy (PT); Procedure: Usual Care (UC)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01556581

211107

Details and patient eligibility

About

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.

Full description

The specific aims of this study are the following:

1. 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.
2. 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.
3. Evaluate the importance of psychosocial factors on outcomes within both groups of treatment.

Enrollment: 119 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

Usual Care (UC)

Active Comparator group

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.

Treatment:

Procedure: Usual Care (UC)

Early Physical Therapy (PT)

Active Comparator group

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.

Treatment:

Procedure: Early Physical Therapy (PT)