Alterations of the Achilles TendonMEDUSAANCT02567058
Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)
A study testing Ultrasound exam and IPAQ questionnaire in people with Alterations of the Achilles Tendon, run by University Hospital, Tours at 1 site in France.
Trial summary
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alterations of the Achilles Tendon
- What is being tested?
- Ultrasound exam and IPAQ questionnaire
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Aug 2015
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Groupe I
- Male
- Between 18 and 60 years-old
- Informed consent form signed
- Affiliated to medical insurance
- Groupe II
Show all 17Show fewer
- Male
- Between 18 and 60 years-old
- Informed consent form signed
- Affiliated to medical insurance
- pathology of lower limb, from surgical treatment, and requiring an immobilization longer than one month and lower than two months, with discharge without support. Inclusion in the study will be done during within 48h from the onset of the immobilization
- Groupe III
- Male
- Between 18 and 60 years-old
- Informed consent form signed
- Affiliated to medical insurance
- Antecedent of unilateral Achilles tendon breakage during the last 10 years (without breakage during the year previous the inclusion).
Who cannot join
- Groupe I
- Know pathologies of collagen
- Antecedent of surgery on studied lower limb, located under the knee
- Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months
- Muscular or neurologic pathology with impact on lower limbs
- Acute pathology able to compromise quality of the research (infectious, organic failure, pain …)
Show all 27Show fewer
- Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …)
- Adult under guardianship
- Person under an exclusion period of other biomedical research
- Groupe II
- Know pathologies of collagen
- Antecedent of surgery on studied lower limb, located under the knee
- Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months
- Muscular or neurologic pathology with impact on healthy lower limb
- Acute pathology able to compromise quality of the research (infectious, organic failure, pain …)
- Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …)
- Adult under guardianship
- Person under an exclusion period of other biomedical research
- Groupe III
- Know pathologies of collagen
- Antecedent of surgery on studied lower limb, located under the knee
- Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months (including a controlateral Achilles tendon breakage)
- Muscular or neurologic pathology with impact on lower limbs
- Acute pathology able to compromise quality of the research (infectious, organic failure, pain …)
- Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones …)
- Adult under guardianship
- Person under an exclusion period of other biomedical research
Trial locations and contacts
1 site in 1 country.
About this study
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity.
The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps.
This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.
Read the detailed description
Musculoskeletal disorders (MSD) are among the main causes of pain and disability in adults. Tendon disorders are an important part of MSD. Among them, the rupture of the Achilles tendon is the most common, with a prevalence of about 18 to 100000. The disorder mostly affects men between 30 and 50 years. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity. Additional tests that we have to explore the Achilles tendon are ultrasound and MRI. They bring mainly morphological information but can not demonstrate the mechanical properties of the tendon.
For this purpose, the laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps. It is therefore important in the exploratory work we propose to have a proven method of calibration of forces applied to the tendon, which is why an ergometer laboratory biomechanics and bioengineering at UT Compiègne is associated with our experiments.
No human study has yet been conducted to evaluate this method in medically relevant situations such as hyper solicitation and incorporated rupture.
This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.
- Conditions
- Alterations of the Achilles Tendon
- Being tested
- Ultrasound exam, IPAQ questionnaire
- Keywords
- Achilles tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examDevice
Also called Achillus, Ergometer
Ultrasound exam with :
- 2 successions of 3 measures repeated for 2 visits (day 0 and day 21) for group I
- 1 succession of 3 measures repeated for 4 visits (day 0, day 14, day 45, day 90)for group II
- 1 succession of 3 measures for group III
IPAQ questionnaireBehavioural
IPAQ questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 3 groups of subjects | Experimental | 3 groups:
* group I : healthy volunters
* group II : patient with an immobilisation (between 1 and 2 months)
* group III : patient with an antecedent of Achilles tendon breakage during the 10 past years
Each group have the same interventions : ultrasound exam, IPAQ questionnaire Receives: Device: Ultrasound exam; Behavioral: IPAQ questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during
This is the measure of received signals of the ultrasound sensors and measures of applied strength on the pedal during plantar flexion efforts.
Untreated data will be treated to extract this following parameters :
- Control of rotational strengths couple applied by the participant
- Simultaneous speed measure of lateral wave along the Achilles tendon The set oh these data will be got with an initial isometric effort at 20, 50, 80% of the de maximal voluntary muscle contraction previously measured
Measured: up to 3 months
Secondary outcomes (3)
score IPAQ questionnaire
Clinical parameter :score questionnaire of average physical activity of persons, determined by IPAQ questionnaire
Measured: up to 3 months
Examination data
Examination data : age, size, weight, laterality, smoking history
Measured: baseline
time of hyper stress
time of hyper stress
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startDec 2012
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alterations of the Achilles TendonStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567058
- Sponsor's protocol ID
- AORT 2011-FP / MEDUSAA
- Acronym
- MEDUSAA
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)
- ClinicalTrials.gov ID
- NCT02567058
- Acronym / sponsor ID
- MEDUSAA / AORT 2011-FP / MEDUSAA
- Conditions
- Alterations of the Achilles Tendon
- Keywords
- Achilles tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Oct 2015 (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.
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity.
The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps.
This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.
Detailed description
Musculoskeletal disorders (MSD) are among the main causes of pain and disability in adults. Tendon disorders are an important part of MSD. Among them, the rupture of the Achilles tendon is the most common, with a prevalence of about 18 to 100000. The disorder mostly affects men between 30 and 50 years. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity. Additional tests that we have to explore the Achilles tendon are ultrasound and MRI. They bring mainly morphological information but can not demonstrate the mechanical properties of the tendon.
For this purpose, the laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps. It is therefore important in the exploratory work we propose to have a proven method of calibration of forces applied to the tendon, which is why an ergometer laboratory biomechanics and bioengineering at UT Compiègne is associated with our experiments.
No human study has yet been conducted to evaluate this method in medically relevant situations such as hyper solicitation and incorporated rupture.
This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 groups of subjects | Experimental | Device: Ultrasound exam, Behavioral: IPAQ questionnaire3 groups: * group I : healthy volunters * group II : patient with an immobilisation (between 1 and 2 months) * group III : patient with an antecedent of Achilles tendon breakage during the 10 past years Each group have the same interventions : ultrasound exam, IPAQ questionnaire |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Groupe I
- Male
- Between 18 and 60 years-old
- Informed consent form signed
- Affiliated to medical insurance
Key exclusion criteria (27 listed)
- Groupe I
- Know pathologies of collagen
- Antecedent of surgery on studied lower limb, located under the knee
- Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months
- Muscular or neurologic pathology with impact on lower limbs
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 |
|---|---|---|
| Ultrasound examAlso: Achillus, ErgometerUltrasound exam with : * 2 successions of 3 measures repeated for 2 visits (day 0 and day 21) for group I * 1 succession of 3 measures repeated for 4 visits (day 0, day 14, day 45, day 90)for group II * 1 succession of 3 measures for group III | Device | 3 groups of subjects |
| IPAQ questionnaireIPAQ questionnaire | Behavioural | 3 groups of subjects |
Primary outcome
Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during
Time frame: up to 3 months
This is the measure of received signals of the ultrasound sensors and measures of applied strength on the pedal during plantar flexion efforts. Untreated data will be treated to extract this following parameters : * Control of rotational strengths couple applied by the participant * Simultaneous speed measure of lateral wave along the Achilles tendon The set oh these data will be got with an initial isometric effort at 20, 50, 80% of the de maximal voluntary muscle contraction previously measured
3 secondary outcomes
score IPAQ questionnaire
Time frame: up to 3 months
Examination data
Time frame: baseline
time of hyper stress
Time frame: up to 3 months
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 2 Oct 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound exam and IPAQ questionnaire in people with Alterations of the Achilles Tendon, run by University Hospital, Tours at 1 site 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 17 inclusion and 27 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 2 Oct 2015. 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 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 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?
Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during (time frame: up to 3 months). 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 2 Oct 2015.