TendinopathyPhase 1NCT00279630
Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
A Phase 1 study testing Orthoses and Exercise in people with Tendinopathy, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Orthoses and Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Biokinesiology and Physical Therapy
Los Angeles, California, 90089
About this study
Official title: 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.
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.
- Conditions
- Tendinopathy
- Being tested
- Orthoses and Exercise
- Keywords
- Tibialis Posterior Tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthoses and ExerciseProcedure or surgery
orthrose and exercise - daily
| Study group | Role | What they receive |
|---|---|---|
| type of exericse | Experimental | type of exercise Receives: Procedure: Orthoses and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index; SF-36; walking distance in 5 minutes; time walking 50-ft; pain following the functional tests
Measured: pre- post- 6-month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJun 2002
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornelia Kulig, University of Southern California
- Investigators
- Kornelia Kulig, PhD, PT, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279630
- Sponsor's protocol ID
- 022051
- Status last verified
- Dec 2014
- First submitted
- 17 Jan 2006
- Last updated
- 3 Dec 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study on Effectiveness of Exercise on Function, Quality of Life and Disability in Patients With Posterior Tibial Tendon Dysfunction
- ClinicalTrials.gov ID
- NCT00279630
- Acronym / sponsor ID
- 022051
- Conditions
- Tendinopathy
- Keywords
- Tibialis Posterior Tendinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type of exericse | Experimental | Procedure: Orthoses and Exercisetype of exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthoses and Exerciseorthrose and exercise - daily | Procedure or surgery | type of exericse |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 16756656Kulig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kornelia Kulig, PhD, PT principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orthoses and Exercise in people with Tendinopathy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.