## Protocol Section
### Identification Module
**NCT ID:** NCT04590079

**Acronym:** Epikarthrose

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 38RC20.088
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Grenoble
### Status Module
#### Completion Date
**Date:** 2022-08-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-24

**Type:** ACTUAL

#### Start Date
**Date:** 2020-12-14

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2020-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-18
**Study First Submit QC Date:** 2020-10-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Remedee SA

**Class:** NETWORK

**Name:** Clinical Investigation Centre for Innovative Technology Network

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Grenoble

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Osteoarthritis

- Peripheral

- Pain

**Keywords:**

- Osteoarthritis

- Pain

- Medical device

- Radiation in millimeter band

- Life quality

- Peripheral

- Treatment

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

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

**Label:** First intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

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

**Label:** Second intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- First intervention group

- Second intervention group

**Description:** Conventional pain treatement with daily sessions with innovative medical device for pain management (radiation in millimeter band) at the rate of 1 to 3 sessions by day of 40 minutes for 3 months.

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

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** At the end of each month for each period of the cross-over, the pain is evaluated using a visual analogue scale (VAS).

**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.

**Time Frame:** 7 months

#### Secondary Outcomes

**Description:** At the end of each of the cross-over period, the quality of life is evaluated with the score obtained using the EQ5D-5L (5-level EuroQol version) questionnaire.

**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.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the depressive state and coping are evaluated with the score obtained using the HAD (Hospital Anxiety and Depression Scale) questionnaire.

**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..

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the functional capacity is evaluated with the score obtained using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire.

**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.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the functional capacity is evaluated with the score obtained using the DREISER (Functional Index for Hand OsteoArthritis) questionnaire.

**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.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the analgesic consumption are assessed by their class, dose and number of dose taken.

**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.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the number of drugs consumed (phytotherapy, homeopathy, food supplements), the number of medical acts, medical consultations, hospitalisations, the number of complementary medicine (acupuncture...) and psycho-behavioural therapies are assessed.

**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.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the number of adverse effects from the medical device is assessed.

**Measure:** Adverse effect from the medical device.

**Time Frame:** 7 months

**Description:** At the end of each of the cross-over period, the sleep quality is evaluated using a qualitative visual satisfaction scale (score between 0 to 10).

**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.

**Time Frame:** 7 months

**Description:** Log files of the medical device are extracted. The number and the duration of each session are analysed.

**Measure:** Description of the medical device use

**Time Frame:** 7 months

**Description:** Open question will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.

**Measure:** Medical device acceptability : descriptive analysis

**Time Frame:** 7 months

### Eligibility Module

**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

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Grenoble

**Country:** France

**Facility:** University Hospital

**Zip:** 38043

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Grenoble

**Name:** Caroline MAINDET, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 16786049

#### See Also Links

**Label:** Bourgeois P, Berenhaum F, Gibert E. Peut-on prévenir l'arthrose ? Arthrolink.

**URL:** https://www.arthrolink.com/fr/dossiers-arthrose/tous-les-dossiers/peut-on-prevenir-l-arthrose

**Label:** Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer (EPIKARD)

**URL:** https://clinicaltrials.gov/ct2/show/NCT03889288?term=EPIKARD&draw=2&rank=1

**Label:** Clinical Investigation Centre for Innovative Technology Network website

**URL:** http://www.cic-it.fr/cic-it-grenoble.php

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
