Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction - Full Text View

Sponsored by:	University of Southern California
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00279630

Purpose

Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and may result in attenuation of the PTT and eventually collapse of the plantar arch or even rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from research related to the management of painful chronic Achilles tendinosis suggests that eccentric strengthening of the posterior tibialis may lead to superior results compared to concentric. The purpose of this research is to determine the effectiveness of treatment interventions used in the management of PTTD.

Condition	Intervention	Phase
Tendinopathy	Procedure: Orthoses and Exercise	Phase I

MedlinePlus related topics: Exercise and Physical Fitness Foot Health Tendinitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction

Further study details as provided by University of Southern California:

Primary Outcome Measures:

Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests

Estimated Enrollment:	45
Study Start Date:	June 2002
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Detailed Description:

All study participants receive a pair of custom made orthoses and perform daily calf-stretches. In addition to the orthoses two groups will perform tibialis posterior specific exercises; one as concentric and the second as eccentric activation. Intervention will last 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pain (> 3 months duration)
Pain localized to the medial ankle and foot
Swelling at the medial ankle
Able to perform a single controlled heel lowering

Exclusion Criteria:

Bilateral posterior tibial tendon dysfunction
Fixed foot deformities
Previous foot surgery
Presence of any other concurrent foot pathology besides posterior tibial tendon dysfunction
Ability to walk only with assistive device
Neurological disorders
Cognitive dysfunction
Uncontrolled cardiovascular disease
Evidence of cord compression
Uncontrolled hypertension
Infection
Severe respiratory disease
Pregnancy
Current or recent history of low back pain
Known rheumatic joint disease
Peripheral vascular disease with sensory loss of the foot.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279630

Contacts

Contact: Kornelia Kulig

323.442.2911

kulig@usc.edu

Locations

United States, California
Department of Biokinesiology and Physical Therapy	Recruiting
Los Angeles, California, United States, 90089
Contact: Kornelia Kulig

Sponsors and Collaborators

University of Southern California

Investigators

Principal Investigator:

Kornelia Kulig, PhD, PT

University of Southern California

More Information

Publications indexed to this study:

Kulig K, Pomrantz AB, Burnfield JM, Reischl SF, Mais-Requejo S, Thordarson DB, Smith RW. Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630]. BMC Musculoskelet Disord. 2006 Jun 6;7:49. Review.

Study ID Numbers:	022051
Study First Received:	January 17, 2006
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00279630
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Southern California:

Tibialis Posterior Tendinopathy

Study placed in the following topic categories:

Tendinopathy
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Posterior Tibial Tendon Dysfunction

Wounds and Injuries
Quality of Life
Disorders of Environmental Origin
Foot Diseases

ClinicalTrials.gov processed this record on January 16, 2009