Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

NCT00279630 | Completed Phase 1

• 1 other identifier: 022051
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy

Keywords

Tibialis Posterior Tendinopathy

Outcome Measures

Primary Outcomes (1)

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

  pre- post- 6-month post

Study Arms (1)

type of exericse

EXPERIMENTAL

type of exercise

Procedure: Orthoses and Exercise

Interventions

Orthoses and Exercise PROCEDURE

orthrose and exercise - daily

type of exericse

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Department of Biokinesiology and Physical Therapy

Los Angeles, California, 90089, United States

Location

Related Publications (1)

• 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. doi: 10.1186/1471-2474-7-49.

  PMID: 16756656 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Orthotic Devices; Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kornelia Kulig, PhD, PT

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: June 1, 2002
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)