NCT04590079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

September 18, 2020

Last Update Submit

February 13, 2023

Conditions

OsteoarthritisPeripheralPain

Keywords

OsteoarthritisPainMedical deviceRadiation in millimeter bandLife qualityPeripheralTreatment

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    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..

    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.

    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.

    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.

    7 months

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

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

Interventions

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.

First intervention groupSecond intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.

You may not qualify if:

  • Patient with chronic inflammatory joint disease (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic rheumatism, spondyloarthritis, lupus),
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38043, France

Location

Related Publications (2)

  • 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.

    PMID: 16786049RESULT

  • 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 osteoarthritis: a crossover randomised trial. Rheumatology (Oxford). 2025 Sep 13:keaf486. doi: 10.1093/rheumatology/keaf486. Online ahead of print.

    PMID: 40971509DERIVED

Related Links

MeSH Terms

Conditions

OsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline MAINDET, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

October 19, 2020

Study Start

December 14, 2020

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

February 14, 2023

Record last verified: 2022-02

Locations

FR(1)