Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer. (Epikarthrose)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Osteoarthritis; Peripheral; Pain

Treatments: Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04590079

38RC20.088

Details and patient eligibility

About

In this study, in addition of conventional treatment, the efficacy of the medical device, Remedee One, in medical care of patients with peripheral osteoarthritis pain is evaluated.

Full description

Osteoarthritis affects 10 millions people in France (17% of the population). It's the second cause of disability and consultation after the cardiovascular diseases in France. For the moment, there is no curative treatment for osteoarthritis The main clinical sign of this disease is pain and care is based on the treatment of pain and on the improvement of functionnal disability. The proposed treatments are mainly based on the use of oral analgesics treatments .

At present, patients report to be insufficiently relieved. New strategies need to be developed. The hypothesis is that the use of an innovative medical device, Remedee One, can reduce the pain felt by patients, improve their quality of life and reduce the analgesics consumption.

The choice is oriented on the peripheral osteoarthritis and excludes spinal osteoarthritis because it's an osteoarthritis always asymptomatic and painless.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult ≥ 50 years
• Patient followed in rhumatology consultation or at the center of the pain of the University Hospital of Grenoble or in liberal for peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, digital) clinically and radiologically confirmed according to the recommendations of the American College of Rheumatology.
• Patient with a pain score on a Visual Analog Scale (VAS) ≥ 4 on a numerical scale of 0 to 10 (average VAS intensity over the week prior to the inclusion visit),
• Patient with a stable analgesic treatment without introduction of a new therapeutic class within the last 3 months,
• Patient with a wrist size compatible with the size of the medical device
• Patient affiliated to social security or beneficiary of such a scheme.
• Having signed a consent to participate.

Exclusion criteria

• Patient with chronic inflammatory joint disease (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic rheumatism, spondyloarthritis, lupus),
• Patient who received an intra-articular corticosteroid injection within 3 months prior to inclusion,
• Patient with surgery scheduled within the next eight months,
• Patient presenting at both wrists a dermatological pathology such as oozing dermatosis, hyper sweating or an unhealed lesion,
• Patient having a piercing or implanted metallic material on both wrists,
• Patient with a tattoo on both wrists,
• Patient deprived of liberty by judicial or administrative decision
• Patient subject to legal protection or unable to express his consent (guardianship or curatorship)
• Patient in exclusion period of another interventional study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

First intervention group

Experimental group

Description:

Patients suffering from peripheral osteoarthritis who will have : 3 months of conventional pain treatment and daily sessions with the medical device - 1 month of wash-out - 3 months of conventional pain treatment.

Treatment:

Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation

Second intervention group

Experimental group

Description:

Patients suffering from peripheral osteoarthritis who will have : 3 months of conventional pain treatment - 1 month of wash-out - 3 months of conventional pain treatment and daily sessions with the medical device.

Treatment:

Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation