N/A
N=119
Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01556581 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Modified Oswestry Disability Index — 23.46; 24.26 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care (UC) (Procedure); Early Physical Therapy (PT) (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Madigan Army Medical Center
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Oswestry Disability Index |
23.46; 24.26 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) |
3.7; 3.7 | — |
| SECONDARY Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change) |
16; 20 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01556581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.