Open Access Study protocol

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

Shane M McClinton12*, Timothy W Flynn3, Bryan C Heiderscheit4, Thomas G McPoil5, Daniel Pinto6, Pamela A Duffy7 and John D Bennett8

Author Affiliations

1 Rocky Mountain University of Health Professions, 561 East 1860 South, Provo, Utah 84606, USA

2 Department of Physical Therapy, Des Moines University, 3200 Grand Avenue, Des Moines, IA 50312, USA

3 Department of Physical Therapy, Rocky Mountain University of Health Professions, 561 East 1860 South, Provo, Utah 84606, USA

4 Department of Orthopedics and Rehabilitation, University of Wisconsin – Madison, 1300 University Avenue, Madison, Wisconsin 53706, USA

5 School of Physical Therapy, Rueckert-Hartman College of Health Professions, Regis University, 3333 Regis Boulevard, Denver, Colorado 80221, USA

6 Department of Physical Therapy and Human Movement Sciences/Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, 645 North Michigan Avenue, Suite 1100, Chicago, Illinois 60611, USA

7 Public Health Program, Des Moines University, 3200 Grand Avenue, Des Moines, Iowa 50312, USA

8 Podiatric Medicine Program, Des Moines University, 3200 Grand Avenue, Des Moines, Iowa 50312, USA

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Trials 2013, 14:414  doi:10.1186/1745-6215-14-414

Published: 3 December 2013

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

Keywords:
Cost; Exercise therapy; Musculoskeletal manipulations; Plantar fasciitis; Podiatry