An observational study in Epicondylitis and Elbow Sprain, sponsored by Decathlon SE. Status unknown at 4 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Decathlon SE · Observational
Decathlon has developed elbowMID500 and elbowSTRAP products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowMID500 only).
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices 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 elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 26 observational studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Decathlon SE is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with acute epicondylitis (stage 1 or 2) or a recent mild elbow sprain whose current condition of their elbow allows them to pursue a usual physical activity.
Exclusion Criteria:
Use of Elbow Mid 500 device during sport practice
Device: Elbow MID 500
Control group of the Elbow Mid 500 group - no medical device used during sport practice
Other: Control group Elbow MID 500
Use of Elbow Strap device during sport practice
Device: Elbow STRAP
Control group of the Elbow Strap group - no medical device used during sport practice
Other: Control group Elbow STRAP
15 patients will be included in this group and will used the medical device Elbow MID 500 during sport practice (at least 2 sport sessions per week), for 6 weeks.
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow MID 500), for at least 2 sport sessions per week during 6 weeks.
15 patients will be included in this group and will used the medical device Elbow STRAP during sport practice (at least 2 sport sessions per week), for 6 weeks.
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device Elbow STRAP), for at least 2 sport sessions per week during 6 weeks.
Functional score
Comparison of the Japanese Elbow Assessment Score System (JOA elbow scale from 0=worst ouctome to 100=best outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model.
Time frame: Change from Baseline functionnal score at 6 weeks
Confidence level (confidence questionnaire related to physical activity)
Gap in the confidence level related to physical activity (scale from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Time frame: 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), for each device model
Time frame: Change from Baseline elbow pain at 6 weeks
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Time frame: 6 weeks of follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Decathlon SE