Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01588730
First received: July 14, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Plantar Fasciitis
Plantar Fasciopathy
Device: Ankle Dorsiflexion Dynasplint
Procedure: Commercially Available Static Night splint
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • FFI score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score


Secondary Outcome Measures:
  • Pain subscale and SROM questionnaire [ Time Frame: 2, 4 and 12 months ] [ Designated as safety issue: No ]

    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.


Enrollment: 26
Study Start Date: June 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01588730

Locations
United States, Pennsylvania
SUN Orthopaedic Group Inc
Lewisburg, Pennsylvania, United States, 17837
Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Principal Investigator: John Furia, MD SUN Orthopaedic Group Inc
  More Information

Publications:
Furia JP, Rompe JD .Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis and Achilles tendinopathy.Curr Opin Orthop 2007;18:102-111

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01588730     History of Changes
Other Study ID Numbers: Dyna-PF 2011
Study First Received: July 14, 2011
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
PF
Dynasplint
ADFD
AFD
Plantar Fasciitis
plantar Fasciopathy

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

ClinicalTrials.gov processed this record on July 20, 2014