Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|