Overview

This trial is active, not recruiting.

Condition low back pain
Treatments usual care (uc), early physical therapy (pt)
Sponsor Madigan Army Medical Center
Collaborator U.S. Army Medical Research and Materiel Command
Start date September 2013
End date August 2017
Trial size 220 participants
Trial identifier NCT01556581, 211107

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The usual care (UC) group will be managed with stepped care approach, receiving a screening exam, advice, education, activity limitation profile and medications if needed, but no early physical therapy.
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.
(Active Comparator)
All subjects in this group will get usual care approach in addition to immediately receiving eight sessions of physical therapy based on a pragmatic treatment based classification system for treating low back pain.
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).

Primary Outcomes

Measure
Modified Oswestry Disability Index
time frame: 12 months

Secondary Outcomes

Measure
Numeric Pain Rating Scale (NPRS)
time frame: 12 months
Fear Avoidance Belief Questionnaire (FABQ)
time frame: 12 Months
Pain Catastrophizing Scale (PCS)
time frame: 12 months
Global Rating of Change (GRC)
time frame: 12 Months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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)

Additional Information

Official title Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Madigan Army Medical Center.