Abstract
BackgroundLow back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period.Methods/DesignThis trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for patients who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive patients randomized to receive care in either group (early physical therapy or usual care only) for the first 4 weeks, and these patients will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the Oswestry Disability Index. Secondary outcome measures are the Global Rating of Change, Patient Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4 weeks, 3 months and 1 year.DiscussionThis trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient’s primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.Trial registrationClinicalTrials.Gov NCT01556581 initially on 14 March 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0959-8) contains supplementary material, which is available to authorized users.
Highlights
Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army
This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while allowing immediate access to physical therapy
The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups
Summary
Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. A separate study compared an initial management strategy of either advanced imaging or physical therapy for low back pain and found that choosing advanced imaging over physical therapy as the initial strategy resulted in significantly greater overall 1-year healthcare costs related to back pain (average of $4,793 more per person) [13]. This means that initial care decisions made by healthcare providers about low back pain, such as early referral to physical therapy, can have a substantial impact on cost and long-term outcomes. While the value of early physical therapy for low back pain has been shown in cohort studies, it has not been evaluated prospectively in a clinical trial
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