Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial

Abstract

Background: A 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.

Methods: A 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.

Discussion: This 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 registration: ClinicalTrials.gov: NCT01865734.

Figure 1

Diagram of participant flow through the study. BMI: Body mass index; DMU: Des Moines University; ePT: Early physical therapy intervention; EQ-5D^TM: European Quality of Life – Five Dimensions; FAAM: Foot and Ankle Ability Measure; GROC: Global rating of change; NPRS: Numeric pain rating scale; PI: Principle investigator; uPOD: Usual podiatric care.

Figure 2

Usual podiatric care (uPOD) represented by the percentage of patients and time relative to initial presentation of podiatric intervention or testing by podiatrists at the study location. MRI: Magnetic resonance imaging; OTC: Over-the-counter.