Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279630
• Other study ID #: 022051
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2006
• Last updated: December 2, 2014
• Start date: June 2002
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posterior Tibial Tendon Dysfunction
• Tendinopathy

Intervention

Procedure:
• Orthoses and Exercise
orthrose and exercise - daily

Locations

Country	Name	City	State
United States	Department of Biokinesiology and Physical Therapy	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests		pre- post- 6-month post	No