Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

August 8, 2013 updated by: Dynasplint Systems, Inc.
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Lewisburg, Pennsylvania, United States, 17837
        • SUN Orthopaedic Group Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours).
Device: Ankle Dorsiflexion Dynasplint
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living
Active Comparator: Static Splint
The control group will be treated with a static splint for a minimum of 6 4 hours each night while sleeping with the end goal of 6-8 hours.
Procedure: Commercially Available Static Night splint
A commericially avilable static night splint will be worn for 4-6 hours during rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain subscale and SROM questionnaire
Time Frame: 2, 4 and 12 months

Secondary outcome measures will include two month, four month, and twelve month overall heel pain reduction measured by the responses to the following questionnaires:

  1. Pain subscale of the validated Foot Function Index (PS-FFI)
  2. A patient-relevant outcome measures (SROM) questionnaire that included generic and condition -specific outcome measures related to pain, function, and satisfaction with the treatment outcome.
2, 4 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynasplint Systems, Inc.

Investigators

  • Principal Investigator: John Furia, MD, SUN Orthopaedic Group Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dyna-PF 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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