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Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain

Unknown statusNot applicableNCT04407884
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Long Term Use of a High Energy Pulsed Heating Device in the Management of Chronic Pain
Interventions
  • Device: Soovu Labs Inc. Pain Relief System
Sponsor
Soovu Labs Inc.
Start date
2020-06-15
Primary completion
2020-09-20
Sex
All
Age range
from 21 Years to 70 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * ● 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 Criteria: * ● 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;

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04407884