Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Plantar Fasciitis Clinical Trial

Official title:

Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01588730
• Other study ID #: Dyna-PF 2011
• Status: Terminated
• Phase: Phase 4
• First received: July 14, 2011
• Last updated: August 8, 2013
• Start date: June 2011

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis
• Plantar Fasciopathy

Intervention

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

Procedure:
• Commercially Available Static Night splint
A commericially avilable static night splint will be worn for 4-6 hours during rest.

Locations

Country	Name	City	State
United States	SUN Orthopaedic Group Inc	Lewisburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.2106/JBJS.I.01651. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFI score	The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score	16 weeks	No
Secondary	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	No