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

Primary Purpose

Osteoarthritis, Peripheral, Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Osteoarthritis, Pain, Medical device, Radiation in millimeter band, Life quality, Peripheral, Treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

First intervention group

Second intervention group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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..
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.
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.
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.
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.
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.
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.
At the end of each of the cross-over period, the analgesic consumption are assessed by their class, dose and number of dose taken.
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.
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.
Adverse effect from the medical device.
At the end of each of the cross-over period, the number of adverse effects from the medical device is assessed.
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.
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).
Description of the medical device use
Log files of the medical device are extracted. The number and the duration of each session are analysed.
Medical device acceptability : descriptive analysis
Open question will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.

Full Information

First Posted
September 18, 2020
Last Updated
February 13, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Remedee SA, Clinical Investigation Centre for Innovative Technology Network
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1. Study Identification

Unique Protocol Identification Number
NCT04590079
Brief Title
Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.
Acronym
Epikarthrose
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Remedee SA, Clinical Investigation Centre for Innovative Technology Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Peripheral, Pain
Keywords
Osteoarthritis, Pain, Medical device, Radiation in millimeter band, Life quality, Peripheral, Treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Second intervention group
Arm Type
Experimental
Arm 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 Type
Device
Intervention Name(s)
Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation
Intervention 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.
Primary Outcome Measure Information:
Title
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.
Description
At the end of each month for each period of the cross-over, the pain is evaluated using a visual analogue scale (VAS).
Time Frame
7 months
Secondary Outcome Measure Information:
Title
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.
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.
Time Frame
7 months
Title
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..
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.
Time Frame
7 months
Title
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.
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.
Time Frame
7 months
Title
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.
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.
Time Frame
7 months
Title
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.
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.
Time Frame
7 months
Title
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.
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.
Time Frame
7 months
Title
Adverse effect from the medical device.
Description
At the end of each of the cross-over period, the number of adverse effects from the medical device is assessed.
Time Frame
7 months
Title
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.
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).
Time Frame
7 months
Title
Description of the medical device use
Description
Log files of the medical device are extracted. The number and the duration of each session are analysed.
Time Frame
7 months
Title
Medical device acceptability : descriptive analysis
Description
Open question will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline MAINDET, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16786049
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.
Results Reference
result
Links:
URL
https://www.arthrolink.com/fr/dossiers-arthrose/tous-les-dossiers/peut-on-prevenir-l-arthrose
Description
Bourgeois P, Berenhaum F, Gibert E. Peut-on prévenir l'arthrose ? Arthrolink.
URL
https://clinicaltrials.gov/ct2/show/NCT03889288?term=EPIKARD&draw=2&rank=1
Description
Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer (EPIKARD)
URL
http://www.cic-it.fr/cic-it-grenoble.php
Description
Clinical Investigation Centre for Innovative Technology Network website

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

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