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

NCT06111118 | Completed

• 3 other identifiers: 161(A)MD2104708600065397TC1FLX8000006UCIV-22-11-041492
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Delayed-Onset Muscle Soreness (DOMS)

Keywords

HeatWraps Flexible; Thermacare; Medical Device; DOMS; Delayed-Onset Muscle Soreness; Heat therapy; Physical exercise

Outcome Measures

Primary Outcomes (1)

• 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".

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

Secondary Outcomes (3)

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

  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

  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)

• Safety and Tolerability of ThermaCare HeatWraps

  Through study completion, an average of 1 year

Study Arms (3)

Immediate ThermaCare HeatWraps

EXPERIMENTAL

Immediately after the completion of standardized exercise ThermaCare HeatWraps will be applied on each leg centered over the quadriceps and lying longitudinally over the muscle for 8 hours. The application of a new ThermaCare HeatWraps will be repeated in the same manner, for 8 hours each, at 24 and 48 hours after exercise (i.e., 3 applications in total).

Device: ThermaCare HeatWraps

Delayed ThermaCare HeatWraps

EXPERIMENTAL

On Day 2, 24 hours after the completion of standardized exercise, Group 2 subjects will apply ThermaCare HeatWraps in the same manner as described above for 8 hours. Subsequent heat wraps will be applied for 8 hours each at 48 and 72 hours after exercise (i.e., 3 applications in total).

Device: ThermaCare HeatWraps

No treatment

NO INTERVENTION

Standardized exercise alone

Interventions

ThermaCare HeatWraps DEVICE

ThermaCare HeatWraps application

Delayed ThermaCare HeatWraps; Immediate ThermaCare HeatWraps

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any gender and any ethnic origin, aged between 18 and 55 years (inclusive), in good general health and able to perform and complete the exercise regimen.
• No significant physical activity causing DOMS in the thighs/quads in the past 4 weeks.
• Body mass index \<40 kg/m2.
• No clinically relevant cardiovascular disease, hepatic disease, diabetes, lower limb neuropathies or recent lower limb injuries.
• Normal blood pressure (systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 60 to 90 mmHg, inclusive) at rest.
• Subject is either not of childbearing potential (defined as biological male sex or postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) and must agree not to start a pregnancy from the signature of the informed consent up to the final visit or practicing one of the following medically acceptable methods of birth control:
• 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).
• Capable of returning to the investigation center for all the visits according to requirement of CIP.
• Willing to comply with the policy, procedure, and restriction of the investigation.
• Capable of actively communicating with the investigator.
• Capable of completing the investigation-related documents.
• Capable of understanding the contents of the informed consent and personal data processing consent and legally ---capable of signing a written informed consent and a personal data processing consent prior to any investigation-related procedures.

You may not qualify if:

• Skin lesions (e.g., rash, bruising, laceration) in the thigh region, or spreading skin conditions (e.g., poison ivy, urticaria) in other regions, or any skin abnormality likely to be aggravated by the device such as dermatological disease or infection, rash, atrophic, fragile or abnormally dry skin, cuts or abrasions at the treatment site.
• Clinically significant abnormalities at medical history and/or physical examination at Visit 1, which in the opinion of the investigator could interfere with the investigation procedures or endpoint evaluations.
• Treatment with alpha or beta agonists/antagonists, any type of anti-inflammatory or analgesic medications, Cox-2 inhibitors, calcium channel blockers, pregabalin (Lyrica), other pain reducers, muscle relaxants, creatine, ephedrine or pseudoephedrine.
• Lactating or pregnant women.
• Suspected or confirmed coronavirus disease 2019 infection at Visit 1.
• History of (within the past 12 months) or current alcohol or substance abuse.
• Any history of radiculopathy and neurological deficits.
• Vulnerable subjects (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
• Subjects who have participated in another interventional investigation within the past 30 days before enrollment or are currently participating in another non-interventional investigation which might impact the outcome of this investigation.
• Subjects who are involved in the conduct of the investigation (i.e., investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
• Known skin hypersensitivity to adhesion products.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Premier Research: collaborator

Study Sites (6)

AMS Centro Médico del Ejercicio

Málaga, Malaga, 29004, Spain

Location

Facultad Ciencias de la Salud Universidad de Malaga

Málaga, Malaga, 29071, Spain

Location

Fisioterapia de la Serna

Madrid, 28020, Spain

Location

Universidad Autonoma de Madrid (UAM) Hospital Universitario La Paz (HULP)

Madrid, 28046, Spain

Location

Medical Sportoledo

Toledo, 45003, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Hyperthermia; Motor Activity

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: January 30, 2023
• Primary Completion: February 13, 2024
• Study Completion: February 16, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

ES (6)