Status:
UNKNOWN
Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain
Lead Sponsor:
Soovu Labs Inc.
Conditions:
Pain
Pain, Chronic
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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 Tr...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- ● 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;
Exclusion
- ● 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;
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04407884
Start Date
June 15 2020
End Date
December 1 2020
Last Update
May 29 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.