Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Des Moines University
Sponsor:
Collaborator:
American Physical Therapy Association
Information provided by (Responsible Party):
Des Moines University
ClinicalTrials.gov Identifier:
NCT01865734
First received: May 24, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical therapy practice and often is associated with chronic symptoms, and disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of care for PHP. Two practice guidelines are available to direct management patterns, but the guidelines and recent evidence of PHP interventions are unclear about the timing and influence of physical therapy in the multidisciplinary management of PHP. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. It is hypothesized that there will be greater improvement and/or reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment provided in the uPOD group will reflect usual management patterns and intervention will be determined by the podiatrist. Treatment provided in the ePT group will be determined by the physical therapist and will focus on impairment-based manual therapy and exercise to the lower half of the body. In addition, evidence-based pain modulating modalities will be integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle Ability measure, the European Quality of Life, Numeric Pain Rating Scale, Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The association between successful outcome based on GROC score and patient expectation of physical therapy or podiatry, and general expectations of symptom improvement will be analyzed. The results of this investigation will help to determine the impact of ePT to inform practice, update existing guidelines to reduce practice variation, and identify the most cost effective treatment for patients with PHP.


Condition Intervention
Fasciitis, Plantar
Other: Physical therapy delivered early after initial podiatry visit
Other: Usual care provided by podiatry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Des Moines University:

Primary Outcome Measures:
  • Foot and Ankle Ability Measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    The average of the least, current, and worst pain in the last week will be used.

  • Global Rating of Change Scale [ Time Frame: 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness ratio [ Time Frame: 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]
    Incremental cost-effectiveness ratio will be calculated per quality-adjusted life year (QALY) gained determined by response on the European Quality of Life - 5 Dimensions

  • Foot and Ankle Ability Measure [ Time Frame: Baseline, 6 weeks, and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: December 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Physical Therapy
Physical therapy delivered early after initial podiatry visit
Other: Physical therapy delivered early after initial podiatry visit
Individuals in the early physical therapy group will receive physical therapy in accordance with the American Physical Therapy Association plantar heel pain practice guidelines and recent evidence in support of manual therapy intervention. Treatment provided will be based on identified impairments and may include manual therapy (joint and soft tissue mobilization/thrust manipulation to the lower half of the body), lower leg and plantar foot specific stretching/self mobilization, foot and lower leg muscle performance training, night splints, taping, over the counter orthotics/heel cup/heel cushion, and iontophoresis. Specific intervention will be selected at the discretion of the treating physical therapist.
Active Comparator: Usual Podiatric Care
Usual care provided by podiatry
Other: Usual care provided by podiatry
Individuals in the usual podiatric care group will receive care typical of podiatry management of plantar heel pain. According to practice guidelines, the first 6 weeks of treatment includes foot taping/padding, home stretching exercises, over the counter arch support/heel cup, shoe recommendations, oral antiinflammatories, and corticosteroid injection. The next 6 months of treatment may include corticosteroid injection, custom orthotics, night splint, immobilization, and physical therapy. If the patient is not responsive after 6 months of treatment, extracorporal shock wave therapy or a fasciotomy surgery is recommended per the guideline. In addition to treatment indicated above, the podiatrist may order radiographs or ultrasound imaging within their scope of practice. Specific intervention and treatment frequency/duration will be selected at the discretion of the treating podiatrist.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Plantar Heel Pain: Tenderness to palpation of the plantar heel, pain associated with first step after waking, or pain with progression of daily weightbearing
  • Patient's primary complaint is plantar heel pain

Exclusion Criteria:

  • Score less than 74/84 on the Foot and Ankle Ability Measure activities of daily living (ADL) subscale
  • Unable to complete questionnaires
  • No treatment for heel pain in last 6 weeks
  • Body mass index greater than 30 kg/m^2
  • Duration of symptoms greater than 1 year
  • Current fracture of the lower leg, ankle, or foot
  • Neurological condition affecting function of lower leg
  • Advanced peripheral artery disease
  • Rheumatoid arthritis
  • Osteoporosis
  • Active cancer
  • Prolonged steroid use
  • Surgery of the lower leg, ankle, or foot
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865734

Contacts
Contact: Shane McClinton, PT, DPT 5152711448 shane.mcclinton@dmu.edu

Locations
United States, Iowa
Des Moines University Recruiting
Des Moines, Iowa, United States, 50312
Contact: Shane McClinton, PT, DPT    515-271-1448    shane.mcclinton@dmu.edu   
Principal Investigator: Shane McClinton, PT, DPT         
Sponsors and Collaborators
Des Moines University
American Physical Therapy Association
Investigators
Principal Investigator: Shane McClinton, PT, DPT Des Moines University
  More Information

No publications provided by Des Moines University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Des Moines University
ClinicalTrials.gov Identifier: NCT01865734     History of Changes
Other Study ID Numbers: 04-13-02
Study First Received: May 24, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Des Moines University:
Fasciitis, Plantar
Heel Pain
Physical Therapy
Podiatry
Musculoskeletal Manipulations
Exercise Therapy

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Foot Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014