TendinopathyTARCINCT02307708
Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
A study testing 8° incline shoe and kinesitherapy in people with Tendinopathy and Rupture of Achilles Tendon, run by Nantes University Hospital at 2 sites in France.
Trial summary
The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendinopathy, Rupture of Achilles Tendon, Chronic Disease
- What is being tested?
- 8° incline shoe and kinesitherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years
- Disease: chronic Achilles tendinopathy de novo or recurrent confirmed by ultrasound
- Patients having signed the informed consent for the study participation
- Patients covered by medical insurance
- Patients having no behavioral disorders
Who cannot join
- History of rupture of the Achilles tendon (= stage 4)
- Antibiotic treatment tendinotoxique (Quinolones, ...)
- Inability to walk more than 30 minutes per day.
- Haglund Syndrome
- Treatment of tendinopathy or being older than six months
- Minors
- Major trust
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.
- Conditions
- Tendinopathy, Rupture of Achilles Tendon, Chronic Disease
- Being tested
- 8° incline shoe, kinesitherapy
- Medical subject headings
- Tendinopathy, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8° incline shoeDevice
Also called Wearing inclined shoes
Wearing inclined shoes for 6 weeks, walking 15 minutes (2 times/day).
The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage.
During the walk we will have:
In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions).
In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction).
kinesitherapyOther
Also called The kinesitherapy for the treatment of tendinopathy
Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| 8° incline shoe | Experimental | The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage.
During the walk we will have:
In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions).
In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction). Receives: Device: 8° incline shoe |
| kinesitherapy | Active comparator | The patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish Receives: Other: kinesitherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
Measured: at Day 0 and 12 weeks
Secondary outcomes (2)
Evolution of amplitude to the tibio-tarsal
Measured: at 12 weeks
Pain Scores on the Visual Analog Scale
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: recruitment difficulties (few patients meeting inclusion criteria, refusal of patients to stop sport activities during 6 weeks,...)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Rousseau, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307708
- Sponsor's protocol ID
- RC13_0043
- Acronym
- TARCI
- Status last verified
- Dec 2017
- First submitted
- 25 Jul 2014
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
- ClinicalTrials.gov ID
- NCT02307708
- Acronym / sponsor ID
- TARCI / RC13_0043
- Conditions
- Tendinopathy, Rupture of Achilles Tendon, Chronic Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties (few patients meeting inclusion criteria, refusal of patients to stop sport activities during 6 weeks,...)
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Dec 2014 (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.
The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8° incline shoe | Experimental | Device: 8° incline shoeThe shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage. During the walk we will have: In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions). In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction). |
| kinesitherapy | Active comparator | Other: kinesitherapyThe patient performs its home therapy and consults his physiotherapist once a week according to the protocol Stanish |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years
- Disease: chronic Achilles tendinopathy de novo or recurrent confirmed by ultrasound
- Patients having signed the informed consent for the study participation
- Patients covered by medical insurance
- Patients having no behavioral disorders
Key exclusion criteria (7 listed)
- History of rupture of the Achilles tendon (= stage 4)
- Antibiotic treatment tendinotoxique (Quinolones, ...)
- Inability to walk more than 30 minutes per day.
- Haglund Syndrome
- Treatment of tendinopathy or being older than six months
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 |
|---|---|---|
| 8° incline shoeAlso: Wearing inclined shoesWearing inclined shoes for 6 weeks, walking 15 minutes (2 times/day). The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage. During the walk we will have: In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions). In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction). | Device | 8° incline shoe |
| kinesitherapyAlso: The kinesitherapy for the treatment of tendinopathyDaily eccentric contraction at home and once per week for 6 weeks with the physiotherapist | Other | kinesitherapy |
Primary outcome
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: at Day 0 and 12 weeks
2 secondary outcomes
Evolution of amplitude to the tibio-tarsal
Time frame: at 12 weeks
Pain Scores on the Visual Analog Scale
Time frame: at 12 weeks
Results and safety
The study was stopped early (reason given: recruitment difficulties (few patients meeting inclusion criteria, refusal of patients to stop sport activities during 6 weeks,...)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
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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.
Bertrand Rousseau principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8° incline shoe and kinesitherapy in people with Tendinopathy and Rupture of Achilles Tendon, run by Nantes University Hospital at 2 sites in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties (few patients meeting inclusion criteria, refusal of patients to stop sport activities during 6 weeks,...)). Results are not available in the source record.
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?
Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS) (time frame: at Day 0 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2017.