Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Dynasplint Systems.

Status and phase: Terminated; Phase 4

Conditions: Plantar Fasciitis; Plantar Fasciopathy

Treatments: Procedure: Commercially Available Static Night splint; Device: Ankle Dorsiflexion Dynasplint

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588730

Dyna-PF 2011

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Dynasplint

Experimental group

Description:

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).

Treatment:

Device: Ankle Dorsiflexion Dynasplint

Static Splint

Active Comparator group

Description:

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.

Treatment:

Procedure: Commercially Available Static Night splint