Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- pain level via numeric pain scale
研究概览
简要总结
The purpose of this study is to evaluate the Soovu Labs pain Relief System in a group of users that represent people most likely to purchase and use the units. This study is called an In Home Users Trial (IHUT). The device is called Soovu and was determined by the FDA to be Class II 510(k) except (C190061 November 2019). Relevant endpoints include ease of use, pain relief, quality of life, and long-term effectiveness.
详细描述
Soovu device description:
From the FDA document (C190061) "The system is indicated to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the temporary relief of menstrual discomfort; the relaxation of muscles; and the temporary increase of local circulation where applied." The devices are constructed following documented ANSI/AAMI ES60601-1, ANSI/AAMI HA60601-1-11, IEC 60601-1-2, IEC 60529, ISO 10993-5, and 10993-10 safety standards.
The device consists of two separate heating units pods that are attached to the body via a ring coated with medical grade adhesive. The units are easily removed from the body. The units are controlled by a phone app that the user downloads to his or her phone and pairs with the units via Bluetooth. The app contains instructional material on how to use the device and general information related to pain management. The user may start and end heat cycles via the app, may adjust the temperature of the unit, and select from one of three heating profiles. The maximum temperature of the unit is 113° F well within accepted safety limits. The three heating algorithms are:
- Waves of heat up 113F that occur about 2 times per minute for up to 30 minutes
- Waves of heat up 113F that occur about 4 times per minute for up to 30 minutes
- Waves of heat up 113 F that occur about 2-3 times per minute for up to 30 minutes. These waves of heat are synchronized with instructions in the app that guide users through relaxed breathing exercises sometimes called box breathing. This option lasts up to 30 minutes.
The user can freely select any of the options, can end the session before the 30 minute time out, and can reduce the maximum temperature of the heat wave from 113° F all via the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● A total of 40 males and females aged 21-70, with recurring lower back will be recruited. Back pain sufferers must report pain at least 3 days/week for the past month. This back pain must be present for at least 6 months. Otherwise, self-reporting moderate good to excellent health;
- •Self-assessed pain intensity level 5 or greater on the 0-10 Numeric Pain scale. This corresponds to a mild to moderate pain intensity;
- •Having signed an Informed Consent Form (ICF), be able to read, comprehend, and sign the informed consent form;
- •Has Apple iPhone version 6 or later IOS operating system and willing to download device app
- •Available for the entire study duration;
- •Willing to comply with all study related requirements;
排除标准
- •● Has or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, immunologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebrovascular or psychiatric disease;
- •Has sciatica where the sciatic component of the pain is greater than the non-radiating pain located in the low back;
- •Skin diseases and disorders (e.g., psoriasis, eczema, scars, wounds and other dermatological lesions...), which may prevent the location of the device to the skin;
- •Taking dietary supplements or herbal remedies inconsistently (on and off) for the month prior to enrollment. If taking these supplements, subjects must stay on a regular daily dose of the product(s) for the duration of the study. If not currently taking these supplements, subjects cannot start taking them during their participation in the study;
- •Patients with neoplasms receiving treatment that may interfere with the study;
- •Subjects who are self-reported to be pregnant, lactating or planning to become pregnant;
- •Having a history of hypersensitivity to similar products;
结局指标
主要结局
pain level via numeric pain scale
时间窗: After week 8 of treatment
11 point Numeric pain scale
次要结局
- Use of device(After week 8 of treatment)
- activity level(After week 8 of treatment)
- Enjoyment of life(After week 8 of treatment)
- Mood levels(After week 8 of treatment)
- ease of use(After week 8 of treatment)
- benefits scale(After week 8 of treatment)
- stress level(After week 8 of treatment)
研究者
charles chabal
Chief Science officer
Soovu Labs Inc.