NCT01556581

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Madigan Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Usual Care (UC)	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.
PROCEDURE	Early Physical Therapy (PT)	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).

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-07-27
• Completion: 2017-10-01
• First posted: 2012-03-16
• Last updated: 2020-07-14
• Results posted: 2020-07-14

Locations

1 site across 1 country: United States