Clinical trial NCT04590079: Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.
Official title: Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer. Evaluation in Patients With Peripheral Osteoarthritis: A Single Center, Prospective, Randomized in Cross-over, Comparative and Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Peripheral
Pain
Keywords: Osteoarthritis
Pain
Medical device
Radiation in millimeter band
Life quality
Peripheral
Treatment
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Remedee SA
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2020-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: First intervention group: patients with peripheral osteoarthritis who will have: 3 months of conventional pain treatment and daily sessions with the medical device followed by 1 month of wash out and then 3 months of conventional pain treatment.

Second intervention group: patients with peripheral osteoarthritis who will have: 3 months of conventional pain treatment followed by 1 month of wash out followed by 3 months of conventional pain treatment and daily sessions with the medical device.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of pain (evaluates with visual analogue scale ) with and without the use of medical device in patients with peripheral osteoarthritis who benefit from their conventional pain treatment.
timeFrame: 7 months
Secondary outcomes:
measure: Comparison of quality of life (evaluated with the EQ5D5L questionnaire), with and without the use of the medical device, in patients with peripheral osteoarthritis who benefit from their conventional pain treatment.
timeFrame: 7 months
measure: Comparison of depressive state and coping (evaluated with the HAD questionnaire), with and without the use of the medical device in patients with peripheral osteoarthritis receiving their conventional pain treatment..
timeFrame: 7 months
measure: Comparison of functional capacity (evaluated with the WOMAC questionnaire) with and without the use of the medical device in patients suffering from osteoarthritis of the lower limbs and benefiting from their conventional pain treatment.
timeFrame: 7 months
measure: Comparison of the functional capacity (evaluatet with the DREISER questionnaire) with and without the use of the medical device in patients with digital osteoarthritis and benefiting from their conventional pain treatment.
timeFrame: 7 months
measure: Number of analgesic consumption, with and without the use of the medical device, in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.
timeFrame: 7 months
measure: Number of care consumption with and without the use of the medical device in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.
timeFrame: 7 months
measure: Adverse effect from the medical device.
timeFrame: 7 months
measure: Charaterization of the sleep quality (evaluated with a qualitative visual satisfaction scale) with and without the use of medical device in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.
timeFrame: 7 months
measure: Description of the medical device use
timeFrame: 7 months
measure: Medical device acceptability : descriptive analysis
timeFrame: 7 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Caroline MAINDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Usichenko TI, Edinger H, Gizhko VV, Lehmann C, Wendt M, Feyerherd F. Low-intensity electromagnetic millimeter waves for pain therapy. Evid Based Complement Alternat Med. 2006 Jun;3(2):201-7. doi: 10.1093/ecam/nel012. Epub 2006 Apr 24.