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.
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 applications against no treatment. Approximately 100 subjects, aged between 18 and 55 years (inclusive), will be enrolled into the investigation. Having given informed consent and personal data processing consent, subjects will undergo a medical screening on Day 1 (Visit 1) to confirm their eligibility to enter the investigation. Subjects who are qualified to enter the investigation will be randomized in a 2:2:1 ratio to one of the following 3 treatment groups, respectively: * Group 1: Immediate ThermaCare HeatWraps application (approximately 40 subjects) * Group 2: Delayed ThermaCare HeatWraps application (starting 24 hours after exercise; approximately 40 subjects) * Group 3: No treatment (approximately 20 subjects) To induce DOMS, the subjects randomized into the investigation will perform a standardized exercise routine of squats between 14:00 and 15:00. An exercise monitor will set the pace at 3 seconds per squat, and subjects will be instructed to flex the hip past 110 degrees. Each set will last for 5 minutes followed by a 3-minute rest, which will be repeated two more times, for a total of 3 sets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
ThermaCare HeatWraps application
AMS Centro Médico del Ejercicio
Málaga, Malaga, Spain
Facultad Ciencias de la Salud Universidad de Malaga
Málaga, Malaga, Spain
Fisioterapia de la Serna
Madrid, Spain
Universidad Autonoma de Madrid (UAM) Hospital Universitario La Paz (HULP)
Madrid, Spain
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
To assess the impact on DOMS pain through Numeric Rating Scale (NRS) after standardized exercise followed by an 8-hour ThermaCare HeatWraps application immediately following exercise or delayed application (24 hours after exercise) versus no treatment. The NRS is an 11-point scale scored from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".
Time frame: At 24 hours after exercise (Groups 1 and 3) and at 48 hours after exercise (Group 2)
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
Daily DOMS pain assessment through Numeric Rating Scale (NRS) across the duration of the entire investigation. The NRS is an 11-point scale scored from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".
Time frame: at 8, 16, 48, and 72 hours after exercise (Groups 1 and 3) and at 32, 40, 72 and 96 hours after exercise (Group 2)
Subjects' global impression of perceived effect (muscle stiffness, ease of movement, flexibility, strength), therapeutic benefit and treatment satisfaction
Subjects' global impression of perceived effect through a unique Patient Global Impression of Severity (PGI-S) scale. The PGI-S is a 1-item questionnaire designed to assess subject's impression of DOMS severity. The subject will be asked to answer to the following questions: Based on your thigh's muscle soreness, how do you rate your muscle stiffness? Based on your thighs' muscle soreness, is there an impairment in your ease of movement? Based on your thighs' muscle soreness, is there an impairment in your flexibility? Based on your thighs' muscle soreness, is there any negative impact on your performance? Based on your thighs' muscle soreness, is there any negative impact on your muscle strength? The subject picks the answer that best describes his/her impression of DOMS severity, according to the PGI-S 7-point scale: 1\. Not present; 2.Very mild; 3. Mild; 4.Moderate; 5.Moderately severe; 6.Severe and 7. Extremely severe
Time frame: At 8, 16, 24, 48 and 72 hours after exercise (Groups 1 and 3) and at 32, 40, 48, 72 and 96 hours after exercise (Group 2)
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Medical Sportoledo
Toledo, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Safety and Tolerability of ThermaCare HeatWraps
Incidence of incidents/adverse events (AEs) as number of events
Time frame: Through study completion, an average of 1 year