Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

This study is currently recruiting participants.
Verified June 2012 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California
ClinicalTrials.gov Identifier:
NCT00279630
First received: January 17, 2006
Last updated: June 15, 2012
Last verified: June 2012

January 17, 2006
June 15, 2012
June 2002
August 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00279630 on ClinicalTrials.gov Archive Site
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Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With 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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tendinopathy
Procedure: Orthoses and Exercise
orthrose and exercise - daily
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Kornelia Kulig 323.442.2911 kulig@usc.edu
United States
 
NCT00279630
022051
Not Provided
Kornelia Kulig, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Kornelia Kulig, PhD, PT University of Southern California
University of Southern California
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP