View Clinical Trial (Medical Research Study)
Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
| City: |
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Tacoma |
| State: |
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Washington |
| Zip Code: |
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98431 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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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. 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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT01556581 |
| Primary Contact: |
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Study Chair
Julie Fritz, PT, PhD
University of Utah
Daniel Rhon, PT, DPT, DSc
Phone: 2539680780
Email: daniel.rhon@us.army.mil
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tacoma, Washington 98431
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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