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

This study has been completed.
Sponsor:
Collaborator:
Saudi Arabian Cultural Mission
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222911
First received: September 20, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Plantar Fasciitis
Device: dorsiflexion night splint
Device: medial arch support
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports: a Prospective Randomized Study

Further study details as provided by University of Pittsburgh:

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

Estimated Enrollment: 75
Study Start Date: August 2005
Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222911

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00222911     History of Changes
Other Study ID Numbers: 0506173
Study First Received: September 20, 2005
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
plantar fasciitis
heel pain
heel spur
night splint
arch support
foot orthosis
physical therapy

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on September 18, 2014