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Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

Primary Purpose

Plantar Fasciitis, Plantar Fasciopathy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ankle Dorsiflexion Dynasplint
Commercially Available Static Night splint
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SUN Orthopaedic Group Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynasplint

Static Splint

Arm 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).

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.

Outcomes

Primary Outcome Measures

FFI score
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
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.

Full Information

First Posted
July 14, 2011
Last Updated
August 8, 2013
Sponsor
Dynasplint Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01588730
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Plantar Fasciopathy
Keywords
PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynasplint
Arm Type
Experimental
Arm 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).
Arm Title
Static Splint
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Ankle Dorsiflexion Dynasplint
Intervention 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) and, this does not affect activities of daily living
Intervention Type
Procedure
Intervention Name(s)
Commercially Available Static Night splint
Intervention Description
A commericially avilable static night splint will be worn for 4-6 hours during rest.
Primary Outcome Measure Information:
Title
FFI score
Description
The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Pain subscale and SROM questionnaire
Description
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.
Time Frame
2, 4 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Furia, MD
Organizational Affiliation
SUN Orthopaedic Group Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUN Orthopaedic Group Inc
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8792046
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.
Results Reference
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PubMed Identifier
12452346
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.
Results Reference
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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
Results Reference
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PubMed Identifier
16119283
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.
Results Reference
background
PubMed Identifier
8973894
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.
Results Reference
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PubMed Identifier
9462907
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.
Results Reference
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PubMed Identifier
10613168
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.
Results Reference
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PubMed Identifier
21048171
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.
Results Reference
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PubMed Identifier
20479445
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.
Results Reference
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PubMed Identifier
1791004
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.
Results Reference
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Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy

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