Clinical trial NCT01588730: Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
Official title: Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Plantar Fasciitis
Plantar Fasciopathy
Keywords: PF
Dynasplint
ADFD
AFD
Plantar Fasciitis
plantar Fasciopathy
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: FFI score
timeFrame: 16 weeks
Secondary outcomes:
measure: Pain subscale and SROM questionnaire
timeFrame: 2, 4 and 12 months
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: SUN Orthopaedic Group Inc
state: Pennsylvania
Study officials:
affiliation: SUN Orthopaedic Group Inc
name: John Furia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.3928/0147-7447-20021101-20.
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
citation: 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. doi: 10.3928/0147-7447-20050701-17.
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. doi: 10.1177/107110079601701203.
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. doi: 10.1177/107110079801900103.
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.
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.
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. doi: 10.7547/1000161.
citation: Wapner KL, Sharkey PF. The use of night splints for treatment of recalcitrant plantar fasciitis. Foot Ankle. 1991 Dec;12(3):135-7. doi: 10.1177/107110079101200301.