Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
|ClinicalTrials.gov Identifier: NCT01588730|
Recruitment Status : Terminated
First Posted : May 1, 2012
Last Update Posted : August 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis Plantar Fasciopathy||Device: Ankle Dorsiflexion Dynasplint Procedure: Commercially Available Static Night splint||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2015|
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.
- 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
- 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:
- Pain subscale of the validated Foot Function Index (PS-FFI)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588730
|United States, Pennsylvania|
|SUN Orthopaedic Group Inc|
|Lewisburg, Pennsylvania, United States, 17837|
|Principal Investigator:||John Furia, MD||SUN Orthopaedic Group Inc|