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

NCT04407884 | Unknown

• 1 other identifier: Soovu 001-20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Pain; Pain, Chronic; Pain, Back

Keywords

heat; analgesia; chronic pain; thermal analgesia; low back pain

Outcome Measures

Primary Outcomes (1)

• pain level via numeric pain scale

  11 point Numeric pain scale

  After week 8 of treatment

Secondary Outcomes (7)

• Mood levels

  After week 8 of treatment

• stress level

  After week 8 of treatment

• Enjoyment of life

  After week 8 of treatment

• Use of device

  After week 8 of treatment

• ease of use

  After week 8 of treatment

Study Arms (1)

study arm

EXPERIMENTAL

Subjects will receive an active study device.

Device: Soovu Labs Inc. Pain Relief System

Interventions

Soovu Labs Inc. Pain Relief System DEVICE

Longnitual follow-up

study arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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;

You may not qualify if:

• ● 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;

Sponsors & Collaborators

• Soovu Labs Inc.: lead

MeSH Terms

Conditions

Pain; Chronic Pain; Back Pain; Agnosia; Low Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• charles chabal, MD

  Soovu Labs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

charles chabal, md

CONTACT

2065794910; Chuck@Soovu.com

Jenny Hapgood

CONTACT

jenny@Soovu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science officer

Model Details: Single group with longitudinal follow-up

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 29, 2020
• Study Start: June 15, 2020
• Primary Completion: September 20, 2020
• Study Completion: December 1, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share