Plantar Fasciitis Treated With Dynamic Splinting

This study has been completed.

Sponsor:

Information provided by:

Dynasplint Systems, Inc.

ClinicalTrials.gov Identifier:

NCT00650884

First received: March 31, 2008

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 31, 2008

Last Updated Date

April 27, 2012

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

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Plantar Fasciitis

Intervention ^ICMJE

Device: Ankle Dorsiflexion Dynasplint System

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.

Other Name: Cross-Over

Study Arm (s)

No Intervention: 1
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.

Intervention: Device: Ankle Dorsiflexion Dynasplint System
Experimental: 2
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.

Intervention: Device: Ankle Dorsiflexion Dynasplint System
3
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.

Intervention: Device: Ankle Dorsiflexion Dynasplint System

Publications *

Guldemond NA, Leffers P, Sanders AP, Emmen H, Schaper NC, Walenkamp GH. Casting methods and plantar pressure: effects of custom-made foot orthoses on dynamic plantar pressure distribution. J Am Podiatr Med Assoc. 2006 Jan-Feb;96(1):9-18.
Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. 2003 May;85-A(5):872-7. Erratum in: J Bone Joint Surg Am. 2003 Jul;85-A(7):1338.
Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10.
Dmitri Luke BS. Plantar fasciitis: a new experimental approach to treatment. Med Hypotheses. 2002 Jul;59(1):95-7. Review.
Ross M. Use of the tissue stress model as a paradigm for developing an examination and management plan for a patient with plantar fasciitis. J Am Podiatr Med Assoc. 2002 Oct;92(9):499-506.
MacKay-Lyons M. Low-load, prolonged stretch in treatment of elbow flexion contractures secondary to head trauma: a case report. Phys Ther. 1989 Apr;69(4):292-6.
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53
Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26
Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7.
Martin JE, Hosch JC, Goforth WP, Murff RT, Lynch DM, Odom RD. Mechanical treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 2001 Feb;91(2):55-62.
Ng A, Beegle T, Rockett AK. Atypical presentation of plantar fasciitis secondary to soft-tissue mass infiltration. J Am Podiatr Med Assoc. 2001 Feb;91(2):89-92.
Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. Review.
Intenzo CM, Wapner KL, Park CH, Kim SM. Evaluation of plantar fasciitis by three-phase bone scintigraphy. Clin Nucl Med. 1991 May;16(5):325-8.
Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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 Number ^ICMJE

NCT00650884

Other Study ID Numbers ^ICMJE

Dynasplint, DYN1-08-022

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

Dynasplint Systems, Inc.

Collaborators ^ICMJE

Not Provided

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

April 2012

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

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