EpicondylitisNCT05552235
Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice
A study testing Elbow SOFT 300 in people with Epicondylitis and Tendonitis Elbow, run by Decathlon SE at 2 sites in France.
Trial summary
Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epicondylitis, Tendonitis Elbow, Elbow Injury
- What is being tested?
- Elbow SOFT 300
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Nov 2022to Mar 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged ≥ 18 years old
- Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)
- The current condition of his/her elbow allows the subject to continue usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
- Subject is affiliated to the French social security regime
Who cannot join
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
- Subject has any medical condition that could impact the study at investigator's discretion
- Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
- Adult subject to legal protection measure
Trial locations and contacts
2 sites in 1 country.
Sophie TALLON contact
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200
Yoann MORVAN, y.morvan@ch-boulogne.fr
Yoann MORVAN
- Not yet recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
Valérie WIECZOREK, valerie.wieczorek@chru-lille.fr
Valérie WIECZOREK
About this study
Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.
- Conditions
- Epicondylitis, Tendonitis Elbow, Elbow Injury
- Being tested
- Elbow SOFT 300, Control group
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow SOFT 300Device
15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.
Control groupOther
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis group | Experimental | Use of Elbow Soft 300 device during sport practice Receives: Device: Elbow SOFT 300 |
| Control group | Other | No medical device used during sport practice Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionnal score
Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)
Measured: Change from Baseline functionnal score at 6 weeks
Secondary outcomes (4)
Confidence level (confidence questionnaire related to physical activity)
Gap in the confidence level related to physical activity (6-item questionnaire with a global score from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control)
Measured: Change from Baseline confidence level at 6 weeks
Elbow pain
Comparison of elbow pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)
Measured: Change from Baseline elbow pain at 6 weeks
Elbow instability
Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)
Measured: Change from Baseline elbow instability at 6 weeks
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control)
Measured: 6 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start15 Nov 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpicondylitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Decathlon SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valérie WIECZOREK, Principal investigator, Centre Hospitalier Universitaire de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552235
- Sponsor's protocol ID
- elbowSOFT300
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice
- ClinicalTrials.gov ID
- NCT05552235
- Acronym / sponsor ID
- elbowSOFT300
- Conditions
- Epicondylitis, Tendonitis Elbow, Elbow Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Decathlon SEIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Sep 2022 (actual)
- 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.
Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthosis group | Experimental | Device: Elbow SOFT 300Use of Elbow Soft 300 device during sport practice |
| Control group | Other | Other: Control groupNo medical device used during sport practice |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is aged ≥ 18 years old
- Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)
- The current condition of his/her elbow allows the subject to continue usual physical activity
- Subject has been informed and is willing to sign an informed consent form
- Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
Key exclusion criteria (5 listed)
- Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
- Subject has any medical condition that could impact the study at investigator's discretion
- Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
- Adult subject to legal protection measure
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 |
|---|---|---|
| Elbow SOFT 30015 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks. | Device | Orthosis group |
| Control group15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks. | Other | Control group |
Primary outcome
Functionnal score
Time frame: Change from Baseline functionnal score at 6 weeks
Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)
4 secondary outcomes
Confidence level (confidence questionnaire related to physical activity)
Time frame: Change from Baseline confidence level at 6 weeks
Elbow pain
Time frame: Change from Baseline elbow pain at 6 weeks
Elbow instability
Time frame: Change from Baseline elbow instability at 6 weeks
Safety (adverse events)
Time frame: 6 weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Sophie TALLON contact
Valérie WIECZOREK principal investigator
Centre Hospitalier Universitaire de Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow SOFT 300 in people with Epicondylitis and Tendonitis Elbow, run by Decathlon SE 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean HEE (07 64 35 00 45 ext. +33, jean.hee@btwin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionnal score (time frame: Change from Baseline functionnal score at 6 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 17 Jan 2023.