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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222911
• Other study ID #: 0506173
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2005
• Last updated: May 19, 2008
• Start date: August 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• dorsiflexion night splint

• medial arch support

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Saudi Arabian Cultural Mission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks
Primary	plantar heel tenderness at baseline and 6 weeks
Primary	plantar heel pain at baseline and 6 weeks
Primary	disability imposed by the heel pain/plantar fasciitis at baseline and 6 weeks
Secondary	medial longitudinal arch height at baseline