search
Back to results

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

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dorsiflexion night splint
medial arch support
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring plantar fasciitis, heel pain, heel spur, night splint, arch support, foot orthosis, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Outcomes

Primary Outcome Measures

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

medial longitudinal arch height at baseline

Full Information

First Posted
September 20, 2005
Last Updated
May 19, 2008
Sponsor
University of Pittsburgh
Collaborators
Saudi Arabian Cultural Mission
search

1. Study Identification

Unique Protocol Identification Number
NCT00222911
Brief Title
Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports
Official Title
Conservative Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Saudi Arabian Cultural Mission

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
plantar fasciitis, heel pain, heel spur, night splint, arch support, foot orthosis, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
dorsiflexion night splint
Intervention Type
Device
Intervention Name(s)
medial arch support
Primary Outcome Measure Information:
Title
the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks
Title
plantar heel tenderness at baseline and 6 weeks
Title
plantar heel pain at baseline and 6 weeks
Title
disability imposed by the heel pain/plantar fasciitis at baseline and 6 weeks
Secondary Outcome Measure Information:
Title
medial longitudinal arch height at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad H Alghadir, MS, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Irrgang, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anthony Delitto, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dane Wukich, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ray Burdett, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs