Delayed-Onset Muscle Soreness (DOMS)DOMSNCT06111118
The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS)
A study testing ThermaCare HeatWraps in people with Delayed-Onset Muscle Soreness (DOMS), run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed-Onset Muscle Soreness (DOMS)
- What is being tested?
- ThermaCare HeatWraps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesSpain
- Study dates
- 30 Jan 2023to 16 Feb 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- Any other condition that, in the opinion of the investigator, interferes with the investigation endpoints/procedures and does not justify the inclusion of the subject in the investigation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Fisioterapia de la Serna
Madrid, 28020
Universidad Autonoma de Madrid (UAM) Hospital Universitario La Paz (HULP)
Madrid, 28046
AMS Centro Médico del Ejercicio
Málaga, Malaga, 29004
Facultad Ciencias de la Salud Universidad de Malaga
Málaga, Malaga, 29071
Medical Sportoledo
Toledo, 45003
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
About this study
Official title: The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS) - An International, Multicenter, Open-label, Randomized Investigation
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.
Read the detailed description
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.
- Conditions
- Delayed-Onset Muscle Soreness (DOMS)
- Being tested
- ThermaCare HeatWraps
- Keywords
- HeatWraps Flexible, Thermacare, Medical Device, DOMS, Delayed-Onset Muscle Soreness, Heat therapy, Physical exercise
- Medical subject headings
- Hyperthermia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermaCare HeatWrapsDevice
ThermaCare HeatWraps application
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: ThermaCare HeatWraps |
| No treatment | No intervention | Standardized exercise alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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)
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".
Measured: 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:
- Not present; 2.Very mild; 3. Mild; 4.Moderate; 5.Moderately severe; 6.Severe and 7. Extremely severe
Measured: 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
Incidence of incidents/adverse events (AEs) as number of events
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start30 Jan 2023
- Primary completion13 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed-Onset Muscle Soreness (DOMS)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111118
- Sponsor's protocol ID
- 161(A)MD21047
- Other IDs
- 08600065397TC1FLX8000006U, CIV-22-11-041492
- Acronym
- DOMS
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS) - An International, Multicenter, Open-label, Randomized Investigation
- ClinicalTrials.gov ID
- NCT06111118
- Acronym / sponsor ID
- DOMS / 161(A)MD21047
- Conditions
- Delayed-Onset Muscle Soreness (DOMS)
- Keywords
- HeatWraps Flexible, Thermacare, Medical Device, DOMS, Delayed-Onset Muscle Soreness, Heat therapy, Physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 1 Nov 2023 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Immediate ThermaCare HeatWraps | Experimental | Device: ThermaCare HeatWrapsImmediately 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). |
| Delayed ThermaCare HeatWraps | Experimental | Device: ThermaCare HeatWrapsOn 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). |
| No treatment | No intervention | –Standardized exercise alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| ThermaCare HeatWrapsThermaCare HeatWraps application | Device | Delayed ThermaCare HeatWraps, Immediate ThermaCare HeatWraps |
Primary outcome
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
Time frame: At 24 hours after exercise (Groups 1 and 3) and at 48 hours after exercise (Group 2)
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".
3 secondary outcomes
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
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
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)
Safety and Tolerability of ThermaCare HeatWraps
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermaCare HeatWraps in people with Delayed-Onset Muscle Soreness (DOMS), run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in Spain.
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 15 inclusion and 12 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: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS) (time frame: At 24 hours after exercise (Groups 1 and 3) and at 48 hours after exercise (Group 2)). 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 4 Apr 2024.