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Completed

NCT Number: NCT00279630

Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Biokinesiology and Physical Therapy

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthoses and Exercise

Procedure

orthrose and exercise - daily

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction

Important dates

Study start
2002
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2006
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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