CompletedNot Applicable

The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS)

Spain102 participantsStarted 2023-01-30

Plain-language summary

This post-market clinical follow-up, open-label, multicenter, randomized, parallel group clinical investigation is designed to investigate the effectiveness, safety, and tolerability of immediate and delayed ThermaCare HeatWraps (medical device) applications against no treatment.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) up to the final visit
✓. Total abstinence from sexual intercourse since the last menses before exposure to the device and up to the final visit
✓. Intrauterine device
✓. Double-barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream) up to the final visit -----Must have personal smartphone (i.e., iOS or Android).

What they're measuring

Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)

Timeframe: At 24 hours after exercise (Groups 1 and 3) and at 48 hours after exercise (Group 2)

Trial details

NCT IDNCT06111118

SponsorAziende Chimiche Riunite Angelini Francesco S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-13

View on ClinicalTrials.gov More Delayed-Onset Muscle Soreness (DOMS) trials