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Clinical Trials/NCT00650884
NCT00650884
Completed
Not Applicable

Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Dynasplint Systems, Inc.4 sites in 1 country66 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plantar Fasciitis
Sponsor
Dynasplint Systems, Inc.
Enrollment
66
Locations
4
Primary Endpoint
Change in Foot Ankle Pain Disability Survey scores
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).

Detailed Description

To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
January 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:
  • Pain on the bottom of the heel
  • Pain that is usually worse upon arising or after long periods of non weight bearing
  • Pain that increases over a period of months
  • Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
  • Morning mobility limitations
  • Preference of patients to "walk on their toes"
  • Paresthesias after non weight bearing (while sitting or lying down or both)
  • Nocturnal pain
  • Patients must be willing and able to sign the informed consent

Exclusion Criteria

  • Achilles tendon injury
  • Acute traumatic rupture of the plantar fascia
  • Calcaneal bursitis
  • Calcaneal neuritis
  • Calcaneal stress fracture
  • Lumbosacral radiculopathy of S1 nerve root
  • Retrocalcaneal bursitis
  • Tarsal tunnel syndrome

Outcomes

Primary Outcomes

Change in Foot Ankle Pain Disability Survey scores

Time Frame: 12 weeks

Study Sites (4)

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