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Clinical Trials/NCT01588730
NCT01588730
Terminated
Phase 4

Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Dynasplint Systems, Inc.1 site in 1 country26 target enrollmentJune 2011
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ConditionsPlantar FasciitisPlantar Fasciopathy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Plantar Fasciitis
Sponsor
Dynasplint Systems, Inc.
Enrollment
26
Locations
1
Primary Endpoint
FFI score
Status
Terminated
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
June 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •All patients will have had a history of at least 3 consecutive months of plantar heel pain well-localized to the plantar fascia.
  • •All patients will have failed an initial treatment of non-weight bearing plantar and Achilles stretching.
  • •Diagnosis will be confirmed by physical examination by a single physician (JPF) with a typical point of maximum tenderness over the medial tubercle of the calcaneus

Exclusion Criteria

  • •rheumatoid arthritis
  • •local infection
  • •pregnancy
  • •patients with tumors
  • •unresolved fractures
  • •severe peripheral vascular disease
  • •history of prior plantar fascia surgery
  • •history of plantar fascia rupture
  • •age \<18 years
  • •recent ( within 6 weeks) steroid injection

Outcomes

Primary Outcomes

FFI score

Time Frame: 16 weeks

The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score

Secondary Outcomes

  • Pain subscale and SROM questionnaire(2, 4 and 12 months)

Study Sites (1)

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