Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tendinopathy	Procedure: Orthoses and Exercise	Phase 1

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction
Study Start Date :	June 2002
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: type of exericse; type of exercise	Procedure: Orthoses and Exercise; orthrose and exercise - daily

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests [ Time Frame: pre- post- 6-month post ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Department of Biokinesiology and Physical Therapy
Los Angeles, California, United States, 90089

Sponsors and Collaborators

University of Southern California

Investigators

Principal Investigator:	Kornelia Kulig, PhD, PT	University of Southern California

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Kornelia Kulig, Professor, University of Southern California
ClinicalTrials.gov Identifier:	NCT00279630 History of Changes
Other Study ID Numbers:	022051
First Posted:	January 19, 2006
Last Update Posted:	December 3, 2014
Last Verified:	December 2014

Keywords provided by Kornelia Kulig, University of Southern California:

Tibialis Posterior Tendinopathy

Additional relevant MeSH terms:

Tendinopathy; Posterior Tibial Tendon Dysfunction; Muscular Diseases; Musculoskeletal Diseases	Tendon Injuries; Wounds and Injuries; Foot Diseases