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CompletedNCT00279630Updated Dec 3, 2014

Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction

A Phase 1 interventional study of Orthoses and Exercise in Tendinopathy, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by University of Southern California · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tendinopathy

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Keywords

  • Tibialis Posterior Tendinopathy
03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    type of exericse

    type of exercise

    Procedure: Orthoses and Exercise

Interventions

  • ProcedureOrthoses and Exercise

    orthrose and exercise - daily

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What researchers measure

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

07

Study locations

1 site
  • Department of Biokinesiology and Physical Therapy
    Los Angeles, California 90089, United States
08

References and documents

Publications

  • 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. PubMed 16756656 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00279630
Lead sponsor
University of Southern California
Responsible party
Kornelia Kulig (Professor, University of Southern California) — Principal investigator
First posted
Jan 19, 2006
Start date
Jun 2002
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 3, 2014

Study contacts

Kornelia Kulig, PhD, PT
principal investigator · University of Southern California
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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