A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function
Unknown statusNot applicableNCT04938271
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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 telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables, Ltd. to promote healing of chronic mild to moderate knee osteoarthritis as shown by decreased disability and relief of pain. In this study, subjects treat themselves at home once/day for an hour using a smart phone to activate the device worn on an e-textile sports knee sleeve. Microcurrent signals are transmitted from a device thru built in conductive pathways to strategic electrodes placed above and below the knee. A proprietary App both activates therapeutic protocols to transmit microcurrent signals as well as allows user-generated recording of the status of knee pain \& function prior to and following each treatment. These records are then transmitted to health professionals using software compliant with human use data transmission regulations including subject anonymity. The rationale that the device would be effective is supported by microcurrent treatment for osteoarthritis at several US clinics including the prestigious Cleveland Clinic as well as by data of published randomized controlled clinical trials. One reason that more persons do not avail themselves of microcurrent therapy is that treatment usually requires several trips to a clinic often requiring considerable travel by a patient who may be in considerable pain. The health provider typically administers therapy in a clinic using electrodes with a desktop sized instrument. Our miniaturization of a microcurrent device and its use with wearable e-textiles such as a knee compression sleeve is a distinct advantage that enables regular use of effective therapy in home-based self-treatment to provide pain relief and improved knee function. Microcurrent electrotherapy represents a significant improvement in pain control and healing since it employs current in the microampere rang…
Study details
- Official title
- A Telemedicine Home-Based Study of Healables Wearable Electroceutical & Sports Sleeve Designed for Pain Relief & Improved Function in Mild to Moderate Knee Osteoarthritis Including in Persons With Chronic Illness Following Sports Injury
- Conditions
- Interventions
- Device: HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve
- Sponsor
- Healables Ltd.
- Collaborators
- Wolfson Medical Center
- Start date
- 2021-11-22
- Primary completion
- 2022-05
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Mild to moderate osteoarthritis with pain and/or dysfunction in one or both knees as defined as Kellgren-Lawrence grade 1-3 as defined by radiograph or arthroscopy 2. Signed informed consent 3. Ages: 18 - 80 years of both genders Exclusion Criteria: 1. Pacemaker or any electrically active implant 2. Health concerns disclosed at screening interview history and physical including initial laboratory values that in the opinion of a study health professional would preclude participation including a serious metabolic, infectious, neoplastic, neurologic or psychiatric disease. 3. Persons who have had knee orthopedic surgery with the exception of arthroscopic surgery since previous arthroscopic surgery is not an exclusion criterion
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04938271