Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy - Full Text View

Purpose

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).

Condition	Intervention	Phase
Plantar Fasciitis Plantar Fasciopathy	Device: Ankle Dorsiflexion Dynasplint Procedure: Commercially Available Static Night splint	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:

FFI score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score

Secondary Outcome Measures:

Pain subscale and SROM questionnaire [ Time Frame: 2, 4 and 12 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	120
Study Start Date:	June 2011
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588730

Contacts

Contact: John Furia, MD

570-524-4446

jfuria@sunortho.com

Locations

United States, Pennsylvania
SUN Orthopaedic Group Inc	Recruiting
Lewisburg, Pennsylvania, United States, 17837
Contact: John Furia, MD 570-524-4446 furia@sunortho.com

Sponsors and Collaborators

Dynasplint Systems, Inc.

Investigators

Principal Investigator:

John Furia, MD

SUN Orthopaedic Group Inc

More Information

Publications:

Batt ME, Tanji JL, Skattum N. Plantar fasciitis: a prospective randomized clinical trial of the tension night splint. Clin J Sport Med. 1996 Jul;6(3):158-62.

Berlet GC, Anderson RB, Davis H, Kiebzak GM. A prospective trial of night splinting in the treatment of recalcitrant plantar fasciitis: the Ankle Dorsiflexion Dynasplint. Orthopedics. 2002 Nov;25(11):1273-5.

Furia JP, Rompe JD .Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis and Achilles tendinopathy.Curr Opin Orthop 2007;18:102-111

Furia JP. The safety and efficacy of high energy extracorporeal shock wave therapy in active, moderately active, and sedentary patients with chronic plantar fasciitis. Orthopedics. 2005 Jul;28(7):685-92.

Mizel MS, Marymont JV, Trepman E. Treatment of plantar fasciitis with a night splint and shoe modification consisting of a steel shank and anterior rocker bottom. Foot Ankle Int. 1996 Dec;17(12):732-5.

Powell M, Post WR, Keener J, Wearden S. Effective treatment of chronic plantar fasciitis with dorsiflexion night splints: a crossover prospective randomized outcome study. Foot Ankle Int. 1998 Jan;19(1):10-8.

Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. A prospective randomized study. Clin Orthop Relat Res. 1999 Nov;(368):190-5.

Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2514-22.

Sheridan L, Lopez A, Perez A, John MM, Willis FB, Shanmugam R. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010 May-Jun;100(3):161-5.

Wapner KL, Sharkey PF. The use of night splints for treatment of recalcitrant plantar fasciitis. Foot Ankle. 1991 Dec;12(3):135-7.

Responsible Party:	Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:	NCT01588730 History of Changes
Other Study ID Numbers:	Dyna-PF 2011
Study First Received:	July 14, 2011
Last Updated:	April 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:

PF
Dynasplint
ADFD

AFD
Plantar Fasciitis
plantar Fasciopathy

Additional relevant MeSH terms:

Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on May 19, 2013