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

NCT ID: NCT00222911

Last Updated: 2008-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-11-30

Brief 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.

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.

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis; heel pain; heel spur; night splint; arch support; foot orthosis; physical therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

dorsiflexion night splint

Intervention Type: DEVICE

medial arch support

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saudi Arabian Cultural Mission

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Principal Investigators

Ahmad H Alghadir, MS, PT

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

James Irrgang, PhD, PT

Role: STUDY_CHAIR

University of Pittsburgh

Anthony Delitto, PhD, PT

Role: STUDY_DIRECTOR

University of Pittsburgh

Dane Wukich, MD

Role: STUDY_DIRECTOR

University of Pittsburgh

Ray Burdett, PhD, PT

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

0506173

Identifier Type: -

Identifier Source: org_study_id