Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Remedee SA | INDUSTRY |
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caroline MAINDET, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16786049 | Result | 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. | |
| 40971509 | Derived | Maindet 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. |
| Label | URL |
|---|---|
| Bourgeois P, Berenhaum F, Gibert E. Peut-on prévenir l'arthrose ? Arthrolink. | View source |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 7 months |
| Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer (EPIKARD) | View source |
| Clinical Investigation Centre for Innovative Technology Network website | View source |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided