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

NCT00222911 | Completed Phase 4

• 1 other identifier: 0506173
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• medial longitudinal arch height at baseline

Interventions

dorsiflexion night splint DEVICE

medial arch support DEVICE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Saudi Arabian Cultural Mission: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Heel Spur

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Bone Diseases

Study Officials

• Ahmad H Alghadir, MS, PT

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• James Irrgang, PhD, PT

  University of Pittsburgh

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Study Completion: November 1, 2006
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (1)