Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Study Overview
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Brief Summary
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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).

Official Title
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Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Conditions
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Plantar Fasciitis, Plantar Fasciopathy

Intervention / Treatment
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* Device: Ankle Dorsiflexion Dynasplint
* Procedure: Commercially Available Static Night splint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynasplint<br>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<br>* 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<br>|
| Active Comparator: Static Splint<br>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<br>* A commericially avilable static night splint will be worn for 4-6 hours during rest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFI score | 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 | 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. | 2, 4 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy