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

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590079
• Other study ID #: 38RC20.088
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: August 24, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain
• Peripheral

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, Remedee SA

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Bourgeois P, Berenhaum F, Gibert E. Peut-on prévenir l'arthrose ? Arthrolink.
•   Clinical Investigation Centre for Innovative Technology Network website
•   Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer (EPIKARD)