Abstract
BackgroundA significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP.MethodsA parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life – Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery generally, and specific to physical therapy and podiatry treatment, will also be analyzed.DiscussionThis study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP. The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines.Trial registrationClinicalTrials.gov: NCT01865734
Highlights
A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability
If physical therapy intervention provided early after initial presentation to a provider for PHP can reduce utilization of healthcare while improving outcomes, this would be a significant contribution to the economic and disability-related burden of PHP. The purpose of this investigation is to compare the outcomes and costs associated with usual podiatric care versus early physical therapy intervention in patients with PHP
Aim 2: Compare the difference in secondary outcome measures using the 3-item numeric pain rating scale (NPRS), and global rating of change (GROC) scale. These measures will be taken concurrently with the Foot and Ankle Ability Measure (FAAM) in the randomized clinical trial to test the null hypothesis that there is no difference in NPRS and Global Rating of Change (GROC) between early physical therapy intervention (ePT) and usual podiatric care (uPOD)
Summary
Study design This investigation will be a block randomized clinical trial comparing participant-reported outcomes and costeffectiveness of ePT and uPOD with follow-up extending to 1 year (Figure 1). The number of participants for this study is based on the power needed to detect between-group differences in the primary outcome measure, the FAAM, at 6 months. In the absence of research comparing physical therapy and podiatry interventions or podiatry interventions using the FAAM as an outcome measure, sample size calculations are based on achieving a clinically meaningful difference between the groups and details from a recent clinical trial by Cleland et al [10] that used similar methods to this investigation. Intervention All patients will attend one visit with a podiatrist where the podiatrist will perform an evaluation and provide intervention based upon usual practice patterns After this visit, the patient will be invited to participate in the study and undergo a baseline examination that will collect data on variables indicated by Table 1. Home program will include less than 5 of Tier 1 or 2 exercises to facilitate adherence [55]
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