Plantar Fasciitis, Plantar Fasciopathy
Conditions
Keywords
PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy
Brief summary
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).
Interventions
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
PROCEDURECommercially Available Static Night splint
A commericially avilable static night splint will be worn for 4-6 hours during rest.
Sponsors
Dynasplint Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFI score | 16 weeks | The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain subscale and SROM questionnaire | 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. |
Countries
United States
Outcome results
None listed