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

NCT04938271 | Unknown

• 3 other identifiers: HEALABLES HEAL-01IIA-719270187-19-WOMC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; wearable; electroceutical; telemedicine; microcurrent; medical device; pain relief; knee dysfunction; smart textile; e-textile; Telehealth; App; iPhone; smartphone; remote treatment; sports injury

Outcome Measures

Primary Outcomes (2)

• Number of device related serious adverse events recorded from baseline to end of study

  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.

  baseline to end of study (8 weeks)

• 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

  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.

  Measured comparing changes from baseline to the end of 4 weeks

Secondary Outcomes (2)

• 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)

  Measured comparing changes from baseline to the end of 4 weeks

• 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)

  Measured comparing changes from baseline to the end of 4 weeks

Other Outcomes (3)

• 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

  Baseline to 8 week visit end of study

• 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)

  Measured comparing changes from baseline to the end of 8 weeks

• 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)

  Measured comparing changes from baseline to the end of 8 weeks

Study Arms (1)

Healables Wearable Microcurrent Electroceutical HEAL-122 with e-Textile Sports Sleeve

EXPERIMENTAL

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

Interventions

HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve DEVICE

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

Healables Wearable Microcurrent Electroceutical HEAL-122 with e-Textile Sports Sleeve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent
• Ages: 18 - 80 years of both genders

You may not qualify if:

• Pacemaker or any electrically active implant
• 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.

Sponsors & Collaborators

• Healables Ltd.: lead
• Wolfson Medical Center: collaborator

Study Sites (1)

Edith Wolfson Medical Center

Holon, 5822012,, Israel

Location

Related Publications (3)

• Zizic TM, Hoffman KC, Holt PA, Hungerford DS, O'Dell JR, Jacobs MA, Lewis CG, Deal CL, Caldwell JR, Cholewczynski JG, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995 Sep;22(9):1757-61.

  PMID: 8523357 BACKGROUND

• Trock DH, Bollet AJ, Dyer RH Jr, Fielding LP, Miner WK, Markoll R. A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. J Rheumatol. 1993 Mar;20(3):456-60.

  PMID: 8478852 BACKGROUND

• Curtis D, Fallows S, Morris M, McMakin C. The efficacy of frequency specific microcurrent therapy on delayed onset muscle soreness. J Bodyw Mov Ther. 2010 Jul;14(3):272-9. doi: 10.1016/j.jbmt.2010.01.009. Epub 2010 Feb 19.

  PMID: 20538225 BACKGROUND

Related Links

• Use of microcurrent treatment for many disorders including arthritis at the Cleveland Clinic

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Alzheimer Disease; Athletic Injuries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries

Study Officials

• Hadar Oz, MD

  Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 24, 2021
• Study Start: November 22, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)