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

NCT01865734 | Completed DMC

• 1 other identifier: 04-13-02
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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 (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale (NPRS), 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.

Conditions

Fasciitis, Plantar

Keywords

Fasciitis, Plantar; Heel Pain; Physical Therapy; Podiatry; Musculoskeletal Manipulations; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Foot and Ankle Ability Measure

  6 months

Secondary Outcomes (4)

• Numeric Pain Rating Scale

  Baseline, 6 weeks, 6 months, 1 year

• Global Rating of Change Scale

  6 weeks, 6 months, 1 year

• Incremental cost-effectiveness ratio

  6 weeks, 6 months, 1 year

• Foot and Ankle Ability Measure

  Baseline, 6 weeks, and 1 year

Study Arms (2)

Early Physical Therapy

EXPERIMENTAL

Physical therapy after initial podiatry visit

Other: Physical therapy after initial podiatry visit

Usual Podiatric Care

ACTIVE COMPARATOR

Usual care provided by podiatry

Other: Usual care provided by podiatry

Interventions

Physical therapy after initial podiatry visit OTHER

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.

Early Physical Therapy

Usual care provided by podiatry OTHER

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, arch support/heel cup, shoe recommendations, oral anti-inflammatories, and corticosteroid injection. The next 6 months may include corticosteroid injection, custom orthotics, night splint, immobilization, and physical therapy. If unresponsive after 6 months of treatment, extracorporal shock wave therapy or a fasciotomy surgery is considered. Additionally, the podiatrist may order radiographs or ultrasound imaging within their scope of practice. Specific intervention will be selected at the discretion of the treating podiatrist.

Usual Podiatric Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Des Moines University: lead
• American Physical Therapy Association: collaborator

Study Sites (1)

Des Moines University

Des Moines, Iowa, 50312, United States

Location

Related Publications (2)

• McClinton SM, Heiderscheit BC, McPoil TG, Flynn TW. Effectiveness of physical therapy treatment in addition to usual podiatry management of plantar heel pain: a randomized clinical trial. BMC Musculoskelet Disord. 2019 Dec 28;20(1):630. doi: 10.1186/s12891-019-3009-y.

  PMID: 31883516 DERIVED

• McClinton SM, Flynn TW, Heiderscheit BC, McPoil TG, Pinto D, Duffy PA, Bennett JD. Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial. Trials. 2013 Dec 3;14:414. doi: 10.1186/1745-6215-14-414.

  PMID: 24299257 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Shane McClinton, PT, DPT

  Des Moines University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 31, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (1)