Plantar Fasciitis Treated With Dynamic Splinting - Full Text View

Sponsor:	Dynasplint Systems, Inc.
Information provided by:	Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00650884

Purpose

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

Condition	Intervention
Plantar Fasciitis	Device: Ankle Dorsiflexion Dynasplint System

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:

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

Estimated Enrollment:	66
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.	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
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.	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650884

Locations

United States, California
Kaiser Permanente
Sacramento, California, United States, 95825
United States, Florida
Orlando Foot & Ankle Center
Orlando, Florida, United States
United States, Georgia
Ankle & Foot Centers, PC
Marietta, Georgia, United States, 30066
United States, Texas
Lopez Foot Ankle Clinic
Ft Worth, Texas, United States, 76164

Sponsors and Collaborators

Dynasplint Systems, Inc.

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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

Responsible Party:	Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00650884 History of Changes
Other Study ID Numbers:	Dynasplint, DYN1-08-022
Study First Received:	March 31, 2008
Last Updated:	June 5, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dynasplint Systems, Inc.:

Dynamic Splinting for low-load, prolonged-duration stretch

Additional relevant MeSH terms:

Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on February 09, 2012