Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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:

        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.
    

Intervention name(s): Usual Care (UC); Early Physical Therapy (PT)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: back pain; primary care; physical therapy