Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis
- Pain
- Peripheral
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04590079
- Collaborators
- Remedee Labs SAS
- Clinical Investigation Centre for Innovative Technology Network
- Investigators
- Principal Investigator: Caroline MAINDET, MD University Hospital, Grenoble
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