Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports

Conservative Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports: a Prospective Randomized Study

The overall purpose of this study is to examine the combined effect of both dorsiflexion night splints and medial arch supports and compare it to the effect of these interventions each by itself in the treatment of plantar fasciitis.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Device: dorsiflexion night splint; Device: medial arch support

Detailed Description

Plantar fasciitis is an overuse injury causing inflammation at the origin of the plantar fascia and is characterized by plantar heel pain that is provoked by taking the first few steps in the morning and by prolonged standing. It is the most common clinical problem that causes inferomedial heel pain in adults. It is estimated that more than two million people receive treatment for plantar fasciitis in the United States each year. Despite its familiarity to physicians, the exact etiology of plantar fasciitis remains obscure. The variety of treatments noted in the literature attests to the uncertainty of the etiology and pathogenesis of plantar fasciitis. It has been suggested that the success of conservative care for the treatment of patients with plantar fasciitis requires a combination of treatment modalities. Although many authors have stated that mechanical therapy should be considered a cornerstone of any effective treatment plan, some debate remains regarding the most effective form of mechanical treatment. The literature provides evidence to support the use of dorsiflexion night splints and medial arch supports in the treatment of plantar fasciitis. A night splint is used to address early morning pain by preventing contracture of the plantar fascia and Achilles tendon overnight. An arch support, on the other hand, addresses the end of the day pain by preventing overstretch of the plantar fascia during prolonged weight bearing. Therefore, both night splints and arch supports may be necessary to treat plantar fasciitis as they complement each other by both controlling nocturnal contracture of the plantar fascia and Achilles tendon and reducing stresses imposed on the plantar fascia during the day, respectively. This prospective randomized study, to the best of our awareness, is the first that addresses this problem by examining the combined effect of these treatment modalities and comparing it to the effect of a night splint or arch support each by itself. We hypothesize that the night splint and arch support together will be more effective in the treatment of plantar fasciitis than night splint or arch support alone in terms of increasing the range of pain-free passive ankle dorsiflexion, relieving heel tenderness and pain, and reducing disability imposed by the heel pain/plantar fasciitis. A secondary hypothesis of this study is that those with limited passive dorsiflexion of the ankle will benefit from a night splint more than those with normal passive dorsiflexion of the ankle and those with a low medial longitudinal arch will benefit from an arch support more than those with a normal medial longitudinal arch in terms of the previously mentioned outcomes. The range of motion will be measured with a goniometer; heel tenderness will be measured with a pressure algometer; and pain and disability will be measured by the Foot Function Index.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• plantar heel pain
• pain is provoked by taking the first few steps in the morning, by standing after prolonged sitting, and/or by prolonged standing
• tenderness localized to the origin of the plantar fascia on the medial calcaneal tubercle

Exclusion Criteria:

• previous foot surgery
• foot trauma within the previous three months
• tarsal tunnel syndrome
• loss of plantar foot sensation
• foot pathology other than plantar fasciitis including tendonitis, bursitis, or calcaneus fracture
• generalized inflammatory disorders associated with the diagnosis of plantar fasciitis including rheumatoid arthritis, ankylosing spondylitis, Reiter's disease, gout, or lupus
• previous treatment of plantar fasciitis with dorsiflexion night splints and/or medial arch supports
• inability or unwillingness to discontinue current treatment modalities that are used for the purpose of plantar fasciitis
• participation in a worker's compensation program
• age of less than 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks
plantar heel tenderness at baseline and 6 weeks
plantar heel pain at baseline and 6 weeks
disability imposed by the heel pain/plantar fasciitis at baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
medial longitudinal arch height at baseline

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Saudi Arabian Cultural Mission
• Investigators: Principal Investigator: Ahmad H Alghadir, MS, PT, University of Pittsburgh; Study Chair: James Irrgang, PhD, PT, University of Pittsburgh; Study Director: Anthony Delitto, PhD, PT, University of Pittsburgh; Study Director: Dane Wukich, MD, University of Pittsburgh; Study Director: Ray Burdett, PhD, PT, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 20, 2008
• Last Update Submitted That Met QC Criteria: May 19, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: physical therapy; plantar fasciitis; heel spur; heel pain; night splint; arch support; foot orthosis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 0506173