Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

NCT01588730 | Terminated Phase 4 DMC

• 1 other identifier: Dyna-PF 2011
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Plantar Fasciitis; Plantar Fasciopathy

Keywords

PF; Dynasplint; ADFD; AFD; Plantar Fasciitis; plantar Fasciopathy

Outcome Measures

Primary Outcomes (1)

• FFI score

  The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score

  16 weeks

Secondary Outcomes (1)

• Pain subscale and SROM questionnaire

  2, 4 and 12 months

Study Arms (2)

Dynasplint

EXPERIMENTAL

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

Static Splint

ACTIVE COMPARATOR

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

Interventions

Ankle Dorsiflexion Dynasplint DEVICE

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

Dynasplint

Commercially Available Static Night splint PROCEDURE

A commericially avilable static night splint will be worn for 4-6 hours during rest.

Static Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead

Study Sites (1)

SUN Orthopaedic Group Inc

Lewisburg, Pennsylvania, 17837, United States

Location

Related 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.

  PMID: 8792046 BACKGROUND

• 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.

  PMID: 12452346 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16119283 BACKGROUND

• 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.

  PMID: 8973894 BACKGROUND

• 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.

  PMID: 9462907 BACKGROUND

• 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.

  PMID: 10613168 BACKGROUND

• 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.

  PMID: 21048171 BACKGROUND

• 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.

  PMID: 20479445 BACKGROUND

• 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.

  PMID: 1791004 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• John Furia, MD

  SUN Orthopaedic Group Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: May 1, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

US (1)