Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Phase 4

Terminated

• Conditions: Plantar Fasciitis; Plantar Fasciopathy
• Interventions: Device: Ankle Dorsiflexion Dynasplint; Procedure: Commercially Available Static Night splint

• Registration Number: NCT01588730
• Lead Sponsor: Dynasplint Systems, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dynasplint	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).
Static Splint	Commercially Available Static Night 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SUN Orthopaedic Group Inc; 🇺🇸 Lewisburg, Pennsylvania, United States