OsteoarthritisEpikarthroseNCT04590079
Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.
A study testing Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation in people with Osteoarthritis and Peripheral, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Peripheral, Pain
- What is being tested?
- Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Osteoarthritis, Peripheral, Pain
- Being tested
- Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation
- Keywords
- Osteoarthritis, Pain, Medical device, Radiation in millimeter band, Life quality, Peripheral, Treatment
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band RadiationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| First intervention group | Experimental | 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. Receives: Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation |
| Second intervention group | Experimental | 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. Receives: Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 months
Secondary outcomes (10)
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
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).
Measured: 7 months
Description of the medical device use
Log files of the medical device are extracted. The number and the duration of each session are analysed.
Measured: 7 months
Medical device acceptability : descriptive analysis
Open question will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Dec 2020
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Remedee SA, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Caroline MAINDET, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590079
- Sponsor's protocol ID
- 38RC20.088
- Acronym
- Epikarthrose
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16786049Maindet C, Giai J, Leroy C, Proust M, Lalami G, Boudry I, Thiers M, Bosson JL, Grange L. Efficacy and safety of a millimetre wave medical device for pain neuromodulation in peripheral OA: a crossover randomized trial. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf486. doi: 10.1093/rheumatology/keaf486.
PubMed 40971509
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04590079
- Acronym / sponsor ID
- Epikarthrose / 38RC20.088
- Conditions
- Osteoarthritis, Peripheral, Pain
- Keywords
- Osteoarthritis, Pain, Medical device, Radiation in millimeter band, Life quality, Peripheral, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Remedee SA, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| First intervention group | Experimental | Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band RadiationPatients 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. |
| Second intervention group | Experimental | Device: Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band RadiationPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band RadiationConventional 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. | Device | First intervention group, Second intervention group |
Primary outcome
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
At the end of each month for each period of the cross-over, the pain is evaluated using a visual analogue scale (VAS).
10 secondary outcomes
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
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
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
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
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
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
Adverse effect from the medical device.
Time frame: 7 months
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 of the medical device use
Time frame: 7 months
Medical device acceptability : descriptive analysis
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Results publication: PubMed 16786049Usichenko 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.
- Derived from this study: PubMed 40971509Maindet C, Giai J, Leroy C, Proust M, Lalami G, Boudry I, Thiers M, Bosson JL, Grange L. Efficacy and safety of a millimetre wave medical device for pain neuromodulation in peripheral OA: a crossover randomized trial. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf486. doi: 10.1093/rheumatology/keaf486.
- Bourgeois P, Berenhaum F, Gibert E. Peut-on prévenir l'arthrose ? Arthrolink.Link provided by the sponsor.
- Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer (EPIKARD)Link provided by the sponsor.
- Clinical Investigation Centre for Innovative Technology Network websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline MAINDET, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation in people with Osteoarthritis and Peripheral, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.