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



Status:Completed
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 60
Updated:9/13/2017
Start Date:February 2012
End Date:December 2016

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Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.

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.

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.

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)
We found this trial at
1
site
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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mi
from
Tacoma, WA
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