Clinical trial NCT01556581: Comparative Effectiveness of Early Physical Therapy Versus Usual Care for Low Back Pain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: back pain
primary care
physical therapy
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
name: William Beaumont Army Medical Center
First posted: 2012-03-16
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: 12 months
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 12 months
measure: Global Rating of Change (GRC) of +3 or More (Minimum Clinically Important Change)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Utah
name: Julie Fritz, PT, PhD
role: STUDY_CHAIR
References:
citation: Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.
citation: Fritz JM, Brennan GP, Hunter SJ, Magel JS. Initial management decisions after a new consultation for low back pain: implications of the usage of physical therapy for subsequent health care costs and utilization. Arch Phys Med Rehabil. 2013 May;94(5):808-16. doi: 10.1016/j.apmr.2013.01.008. Epub 2013 Jan 18.
citation: Fritz JM, Cleland JA, Speckman M, Brennan GP, Hunter SJ. Physical therapy for acute low back pain: associations with subsequent healthcare costs. Spine (Phila Pa 1976). 2008 Jul 15;33(16):1800-5. doi: 10.1097/BRS.0b013e31817bd853.
citation: Rhon DI, Miller RB, Fritz JM. Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2018 Oct 1;43(19):1313-1321. doi: 10.1097/BRS.0000000000002619.
citation: Rhon D, Fritz J. COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:423. doi: 10.1186/s13063-015-0959-8.