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A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function (HEAL01WMCOA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04938271
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborator:
Wolfson Medical Center
Information provided by (Responsible Party):
Healables Ltd.

Brief Summary:

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 range, 1000 times less than that of Transcutaneous Electrical Nerve Stimulator (TENS) devices that transmit millicurrent electrical signals. This study is designed to demonstrate use of a wearable microcurrent electroceutical at home for subjects to self-treat at their leisure in a comfortable environment that facilitates healing. Moreover, data communication via a smart phone App to health providers enables digital telemedicine for rapid collation and interpretation of relevant data.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label telemedicine home-based study to ascertain the potential effects of an App-driven wearable microcurrent electroceutical docked with an e-textile sports sleeve to relieve pain and improve function in subjects with mild to moderate knee arthritis
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healables Wearable Microcurrent Electroceutical HEAL-122 with e-Textile Sports Sleeve
Subjects activate electroceutical at home for 60 minutes (+/- 20 minutes) daily, 5 times per week, for 4 weeks
Device: HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve
Using a bluetooth connected iPhone, subject activates the HEAL-122 electroceutical device that is docked onto an e-textile sports knee sleeve worn on the osteoarthritic knee




Primary Outcome Measures :
  1. Number of device related serious adverse events recorded from baseline to end of study [ Time Frame: baseline to end of study (8 weeks) ]
    The number of device related serious adverse events that occur in each subject during the entire eight weeks of the study including both the four weeks of active treatment as well as during the four weeks following treatment when potential residual effects of treatment will be observed.

  2. Number of Subjects with Device Treatment-Related Effects on Knee Pain and Dysfunction as Measured by Changes from Baseline to 4 week End of Treatment in the International Knee Documentation Committee (IKDC) Osteoarthritis Index [ Time Frame: Measured comparing changes from baseline to the end of 4 weeks ]
    Measurements of the International Knee Documentation Committee (IKDC) Osteoarthritis Index will be recorded by the investigator at the clinic at baseline and at the 4 week end of active treatment period. IKDC contains 10 questions; scoring 0 to 87 points in total (0 is worst and 87 is best). Study is intended to compare IKDC score between the 2 time points to determine possible improvement of worsening during the 4 week active treatment period.


Secondary Outcome Measures :
  1. Number of Subjects with Device Treatment-Related Effects on Knee Pain and Dysfunction as Measured by Changes from Baseline through the 4 week End of Treatment Period using the 12-Question Knee Injury and Osteoarthritis Outcome Score (KOOS-12) [ Time Frame: Measured comparing changes from baseline to the end of 4 weeks ]
    Measurements using the 12 question Knee injury and Osteoarthritis Outcome Score (KOOS-12) for knee pain and dysfunction will be recorded at baseline and weekly to the end of the 4 week active treatment period by each subject at home using a smart phone application (App) displaying a 5-point scale (0 to 4 points) for each of the 12 questions. In this scale, a higher number represents a worse outcome.

  2. Number of Subjects with Device Treatment-Related Effects on Knee Pain as Measured by Changes from Baseline to the 4 week End of Treatment Period in the Wong-Baker Visual Analog Scale (VAS) [ Time Frame: Measured comparing changes from baseline to the end of 4 weeks ]
    Measurements using the Wong-Baker Visual Analog Scale (VAS) for knee pain will be recorded at baseline and prior to and after each treatment during the 4 week active treatment period by each subject at home using a smart phone application (App) that displays the 11-point scale (0 to 10 points) VAS scale. In this scale, a higher number represents a worse outcome.


Other Outcome Measures:
  1. Number of Subjects with Device Treatment-Related Effects on Knee Pain and Dysfunction as Measured by Changes from Baseline to 8 weeks End of the Study in the International Knee Documentation Committee (IKDC) Osteoarthritis Index [ Time Frame: Baseline to 8 week visit end of study ]
    Measurements of the International Knee Documentation Committee (IKDC) Osteoarthritis Index will be recorded by the investigator at the clinic at baseline and at the 8 week end of the study. IKDC contains 10 questions; scoring 0 to 87 points in total (0 is worst and 87 is best). Study is intended to compare IKDC score between the 2 time points to determine possible improvement of worsening during the study comparing changes from the baseline to the 8 week end of the study.

  2. Number of Subjects with Device Treatment-Related Effects on Knee Pain and Dysfunction as Measured by Changes from Baseline through the 8 week End of the Study using the 12-Question Knee Injury and Osteoarthritis Outcome Score (KOOS-12) [ Time Frame: Measured comparing changes from baseline to the end of 8 weeks ]
    Measurements using the 12 question Knee injury and Osteoarthritis Outcome Score (KOOS-12) for knee pain and dysfunction will be recorded at baseline and weekly to the study end at 8 weeks by each subject at home using a smart phone application (App) displaying a 5-point scale (0 to 4 points) for each of the 12 questions. In this scale, a higher number represents a worse outcome. Study is intended to compare KOOS-12 score between the 2 time points to determine possible improvement of worsening during during the study comparing changes from the baseline to the 8 week end of the study.

  3. Number of Subjects with Device Treatment-Related Effects on Knee Pain as Measured by Changes from Baseline through the 8 Weeks End of the Study in the Wong-Baker Visual Analog Scale (VAS) [ Time Frame: Measured comparing changes from baseline to the end of 8 weeks ]
    Measurements using the Wong-Baker Visual Analog Scale (VAS) for knee pain will be recorded at baseline and, after the end of the 4 week active treatment period, weekly during the 4 week follow-up period to the end of week 8, by each subject at home using a smart phone application (App) that displays the 11-point scale (0 to 10 points) VAS scale. In this scale, a higher number represents a worse outcome. Study is intended to compare the VAS score between the 2 time points to determine possible improvement of worsening during during the study comparing changes from the baseline to the 8 week end of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938271


Contacts
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Contact: George H Lowell, MD 972-54-750-9235 ghlowelll@healables.com

Locations
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Israel
Edith Wolfson Medical Center Recruiting
Holon, Israel, 5822012,
Contact: Hadar Oz, MD    ‭+972 50-8217675‬    ozz@wmc.gov.il   
Contact: Mary Israelson, RN    ‭050-7704618‬    neuresearch@wmc.gov.il   
Sub-Investigator: Yaron Haimovich, MD         
Sponsors and Collaborators
Healables Ltd.
Wolfson Medical Center
Investigators
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Principal Investigator: Hadar Oz, MD Edith Wolfson Medical Center
Additional Information:
Publications:
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Responsible Party: Healables Ltd.
ClinicalTrials.gov Identifier: NCT04938271    
Other Study ID Numbers: HEALABLES HEAL-01
IIA-71927 ( Other Grant/Funding Number: Israel Innovation Authority )
0187-19-WOMC ( Other Identifier: Edith Wolfson Medical Center, Holon, Israel )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Healables Ltd.:
osteoarthritis
wearable
electroceutical
telemedicine
microcurrent
medical device
pain relief
knee dysfunction
smart textile
e-textile
Telehealth
App
iPhone
smartphone
remote treatment
sports injury
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases