Plantar Fasciitis Treated With Dynamic Splinting - Tabular View

Tracking Information

First Received Date ^ICMJE

March 31, 2008

Last Updated Date

June 5, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Foot Ankle Pain Disability Survey scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00650884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Plantar Fasciitis Treated With Dynamic Splinting

Official Title ^ICMJE

Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Brief Summary

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).

Detailed Description

To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment

Condition ^ICMJE

Plantar Fasciitis

Intervention ^ICMJE

Device: Ankle Dorsiflexion Dynasplint System

Study Arms / Comparison Groups

No Intervention: ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CONTROL PATIENTS will only be treated with Standard of Care during this 12 week trial, but will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch after completion of this study.
Experimental: ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). EXPERIMENTAL PATIENTS will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
Other: ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CROSS-OVER patients will be initially treated only with Standard of Care, and after six weeks, they will be Crossed-Over and fit with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:

Pain on the bottom of the heel
Pain that is usually worse upon arising or after long periods of non weight bearing
Pain that increases over a period of months
Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
Morning mobility limitations
Preference of patients to "walk on their toes"
Paresthesias after non weight bearing (while sitting or lying down or both)
Nocturnal pain
Patients must be willing and able to sign the informed consent

Exclusion Criteria:

Achilles tendon injury
Acute traumatic rupture of the plantar fascia
Calcaneal bursitis
Calcaneal neuritis
Calcaneal stress fracture
Lumbosacral radiculopathy of S1 nerve root
Retrocalcaneal bursitis
Tarsal tunnel syndrome

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00650884

Responsible Party

Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.

Study ID Numbers ^ICMJE

Dynasplint, DYN1-08-022

Study Sponsor ^ICMJE

Dynasplint Systems, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Dr Mathew M John, DPM	Ankle & Foot Centers, PC
Study Director:	Buck Willis, PhD	Dynasplint Systems, Inc.

Information Provided By

Dynasplint Systems, Inc.

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP