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CompletedNCT00222911Updated May 20, 2008

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

A Phase 4 interventional study of dorsiflexion night splint and medial arch support in Plantar Fasciitis, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plantar Fasciitis

Keywords

  • plantar fasciitis
  • heel pain
  • heel spur
  • night splint
  • arch support
  • foot orthosis
  • physical therapy
03

In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's planned enrollment of 75 is above the median of 54 across 192 interventional studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Interventions

  • Devicedorsiflexion night splint
  • Devicemedial arch support
06

What researchers measure

Primary outcomes

  1. the range of pain-free passive ankle joint dorsiflexion at baseline and 6 weeks

  2. plantar heel tenderness at baseline and 6 weeks

  3. plantar heel pain at baseline and 6 weeks

  4. disability imposed by the heel pain/plantar fasciitis at baseline and 6 weeks

Secondary outcomes

  1. medial longitudinal arch height at baseline

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00222911
Lead sponsor
University of Pittsburgh
Collaborators
Saudi Arabian Cultural Mission
First posted
Sep 22, 2005
Start date
Aug 2005
Completion
Nov 2006
Last update
May 20, 2008

Study contacts

Ahmad H Alghadir, MS, PT
principal investigator · University of Pittsburgh
James Irrgang, PhD, PT
study chair · University of Pittsburgh
Anthony Delitto, PhD, PT
study director · University of Pittsburgh
Dane Wukich, MD
study director · University of Pittsburgh
Ray Burdett, PhD, PT
study director · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

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