NCT06111118已完成不适用
The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS) - An International, Multicenter, Open-label, Randomized Investigation
Aziende Chimiche Riunite Angelini Francesco S.p.A12 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 12
- 主要终点
- Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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
- •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.
- •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.
结局指标
主要结局
Difference in DOMS scores using an 11-point Numeric Rating Scale (NRS)
时间窗: 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".
次要结局
- Safety and Tolerability of ThermaCare HeatWraps(Through study completion, an average of 1 year)
- 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))
研究者
研究点 (12)
Loading locations...
相似试验
招募中
不适用
The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical InvestigationPain ManagementOsteoarthritisNCT06650631Aziende Chimiche Riunite Angelini Francesco S.p.A80
已完成
不适用
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back PainChronic PainLow Back PainHeatAnalgesiaNCT04109703Soovu Labs Inc.100
已完成
不适用
Chronic Heat Therapy for Improving Vascular HealthCardiovascular DiseasesNCT02518399University of Oregon20
进行中（未招募）
不适用
A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLSRestless Legs SyndromeNCT06076499Noctrix Health, Inc.325
已完成
2 期
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨Cutaneous LeishmaniasisNCT02687971Drugs for Neglected Diseases130