FibromyalgiaFibrepikNCT05058092
Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia
A study testing Immediate Remedee Solution and Delayed Remedee Solution in people with Fibromyalgia, run by Remedee SA at 8 sites in France.
Trial summary
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Immediate Remedee Solution and Delayed Remedee Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Nov 2021to 28 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
- FIQ score ≥ 39 (moderate and higher forms) on the day of inclusion (D0),
- with a smartphone that runs on Android 8 and iOS 12 or later,
- agreeing the installation of the Fibrepik app on the smartphone,
- agreeing the collection of the number of steps measured by the smartphone,
- agreeing the installation of the Google Fit app for patients whose smartphone runs on Android (necessary for the collection of the number of steps),
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- wrist size compatible with the size M or L of the wristband template,
- affiliated to the social security system or beneficiary of such a system,
- who have signed a consent to participate.
Who cannot join
- with a characterized depressive episode according to the DSM 5,
- substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment.
- with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...),
- person in civil proceedings,
- having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion,
- with a surgical implant, tattoo or piercing on one of the wrists,
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- allergic to metals and/or silicone,
- referred to articles L1121-5 to L1121-8 of the French Public Health Code (CSP): Pregnant, parturient or nursing woman; Person deprived of liberty by judicial or administrative decision; Person subject to a legal protection measure or unable to express his/her consent; Person under psychiatric care
- in a period of exclusion from other interventional research.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
University Hospital of Grenoble Alps
Grenoble
CHU de Montpellier
Montpellier
Cabinet libéral Dr. Lorenzi-Pernot
Mornant
Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris
Paris
CHU de Rouen
Rouen
Hôpital Foch
Suresnes
Centre Hospitalier de Valenciennes
Valenciennes
Médipôle hôpital mutualiste
Villeurbanne
About this study
Official title: The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.
Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.
Read more
The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.
The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.
- Conditions
- Fibromyalgia
- Being tested
- Immediate Remedee Solution, Delayed Remedee Solution
- Keywords
- pain, sleep disturbances, millimeter waves
- Medical subject headings
- Fibromyalgia, Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Remedee SolutionDevice
- D0 to M3: Remedee Solution + medical care
- M3 to M6: Remedee Solution without personalized support + medical care
- M6 to M9: medical care only
Delayed Remedee SolutionDevice
- D0 to M3: medical care only
- M3 to M6: Remedee Solution + medical care
- M6 to M9: Remedee Solution without personalized support + medical care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Remedee Solution consists of:
* a wristband designed to deliver millimeter wave
* a mobile application that allows the patient to follow his treatment sessions
* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment
The use of the Remedee Solution start at the randomization day (D0) Receives: Device: Immediate Remedee Solution |
| Control | Other | The Remedee Solution consists of:
* a wristband designed to deliver millimeter wave
* a mobile application that allows the patient to follow his treatment sessions
* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment
The use of the Remedee Solution start at three months (M3) after randomization day Receives: Device: Delayed Remedee Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3).
A decrease in FIQ score ≥ 14% is considered clinically meaningful (Bennett et al., 2009)
Measured: 3 months
Secondary outcomes (16)
Evolution of the quality of sleep between D0 and M3 on the Pittsburg Sleep Quality Index (PSQI) questionnaire.
The score of the PSQI questionnaire is between 0 and 21. The higher score (21) means the worse quality of sleep.
Measured: 3 months
Evolution between D0 and M3 of the average pain score over the week on a Visual Analogic Scale (VAS).
The score of the VAS is beetween 0 and 10. The higher score (10) means the worse pain.
Measured: 3 months
Evolution between D0 and M3 of anxiety and depression on the Hospital and Anxiety Depression scale (HAD).
The HAD scale has two dimensions: anxiety score is between 0 and 21 and depression score is between 0 and 21. The higher score means the worse anxiety or depression.
To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores:
- <7 : no symptomatology
- 8 to 10: doubtful symptomatology
- >11 : definite symptomatology.
Measured: 3 months
Evolution between D0 and M3 of fatigue between the two groups on the Multidimensional Fatigue Inventory questionnaire (MFI20)
The MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.
The score of each dimension is between 4 and 20. Higher score correspond with more acute levels of fatigue.
Measured: 3 months
Evolution of analgesic, antidepressant and sleeping pill intake between D0 and M3
Patient-reported class, dose and number of analgesic doses, as well as dose and number of antidepressant and sleep medication doses. Both self-prescription and heteroprescription will be counted.
Measured: 3 months
Consumption of care between D0 and M3
number of:
- care (procedures, medical consultations, hospitalizations),
- complementary care (acupuncture, osteopath, naturopath, etc.),
- psycho-behavioral therapies,
- complementary treatments (phytotherapy, homeopathy, food supplements).
Measured: 3 months
Evolution between D0 and M3 of the general quality of life on the EQ-5D-5L questionnaire
The EQ-5D-5L is a standardized instrument developped by the Euroquol Group as a measure of health-related quality of life. The EQ-5D-5L contains 5 questions (5Q) with response rated in 5 level (5L) and a visual-analogue-scale between 0 and 100. Responses of the 5 questions results to index.
Measured: 3 months
Evolution between D0 and M3 of physical activity on the Global Physical Activity Questionnaire (GPAC).
Each object has a specific code starting from P1 to P16 and then activity is calculated in MET value. For Work and Recreational domains, Moderate MET value is 4.0 and Vigorous MET value is 8.0 while for Transport domains MET value is 4.0
Measured: 3 months
Evolution of number of steps measured by the subject's smartphone collected from D0 to M3 through the Fibrepik mobile application.
Measured: 3 months
Impression of the disease change by the patient on the Patient Global Impression of Change (PGIC) at M3
The PGIC scale is a 7 point scale depicting a patient's rating of overall improvement.
Measured: 3 months
Impression of the disease change by the caregiver on the Clinician Global Impression of Change (CGIC) scale at M3
The CGIC scale is a 7 point scale depicting a patient's rating of overall improvement.
Measured: 3 months
Frequency of use of the wristband on the six months of use it
Analyses of log file of wristband
Measured: month 6 for Intervention groupe and month 9 for control group
Usability of the wristband on the modular evaluation of key Components of User Experience (meCUE) questionnaire.
The questionnaire includes 30 items divided into four independent modules: product perception, emotions, consequence of use and global evaluation.
For modules 1 to 3, the user indicates his or her level of agreement with statements on a 7-point Likert scale, from "strongly disagree" to "strongly agree.
The last question of the meCUE (module 4) asks the user to give an overall evaluation of the product on a scale from - 5 (bad) to + 5 (good).
Measured: month 6 for Intervention groupe and month 9 for control group
Remedee Solution satisfaction questionnaire (questionnaire created by the sponsor)
This questionnaire specific to the Remedee Solution includes three parts in order to evaluate the patient's satisfaction with the bracelet, the mobile application and the support. A global score between 0 and 100 is given for each part and qualitative questions allow to better understand this global score
Measured: month 6 for Intervention groupe and month 9 for control group
Number, description, classification (serious/non-serious) of adverse effects
Measured: 9 months
Outcomes 1 to 12 evaluated at 6 months and at 9 months.
We repeat the measure of outcomes 1 to 12 at 6 and 9 months from the randomization to see the evolution of each of them
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Nov 2021
- Primary completion15 Jul 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in two groups of type: Immediate Solution vs. Delayed Solution
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remedee SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline MAINDET, MD, Principal investigator, University Hospital of Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058092
- Sponsor's protocol ID
- Remedee3/Fibrepik
- Acronym
- Fibrepik
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chipon E, Bosson JL, Minier L, Dumolard A, Vilotitch A, Crouzier D, Maindet C. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial. Trials. 2022 Sep 5;23(1):740. doi: 10.1186/s13063-022-06693-z.
PubMed 36064731
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial
- ClinicalTrials.gov ID
- NCT05058092
- Acronym / sponsor ID
- Fibrepik / Remedee3/Fibrepik
- Conditions
- Fibromyalgia
- Keywords
- pain, sleep disturbances, millimeter waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Remedee SAIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Sep 2021 (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.
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.
Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.
The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.
The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization in two groups of type: Immediate Solution vs. Delayed Solution
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Immediate Remedee SolutionThe Remedee Solution consists of: * a wristband designed to deliver millimeter wave * a mobile application that allows the patient to follow his treatment sessions * a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment The use of the Remedee Solution start at the randomization day (D0) |
| Control | Other | Device: Delayed Remedee SolutionThe Remedee Solution consists of: * a wristband designed to deliver millimeter wave * a mobile application that allows the patient to follow his treatment sessions * a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment The use of the Remedee Solution start at three months (M3) after randomization day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
- FIQ score ≥ 39 (moderate and higher forms) on the day of inclusion (D0),
- with a smartphone that runs on Android 8 and iOS 12 or later,
- agreeing the installation of the Fibrepik app on the smartphone,
- agreeing the collection of the number of steps measured by the smartphone,
Key exclusion criteria (9 listed)
- with a characterized depressive episode according to the DSM 5,
- substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment.
- with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...),
- person in civil proceedings,
- having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion,
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 |
|---|---|---|
| Immediate Remedee Solution* D0 to M3: Remedee Solution + medical care * M3 to M6: Remedee Solution without personalized support + medical care * M6 to M9: medical care only | Device | Intervention |
| Delayed Remedee Solution* D0 to M3: medical care only * M3 to M6: Remedee Solution + medical care * M6 to M9: Remedee Solution without personalized support + medical care | Device | Control |
Primary outcome
Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3).
Time frame: 3 months
A decrease in FIQ score ≥ 14% is considered clinically meaningful (Bennett et al., 2009)
16 secondary outcomes
Evolution of the quality of sleep between D0 and M3 on the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Time frame: 3 months
Evolution between D0 and M3 of the average pain score over the week on a Visual Analogic Scale (VAS).
Time frame: 3 months
Evolution between D0 and M3 of anxiety and depression on the Hospital and Anxiety Depression scale (HAD).
Time frame: 3 months
Evolution between D0 and M3 of fatigue between the two groups on the Multidimensional Fatigue Inventory questionnaire (MFI20)
Time frame: 3 months
Evolution of analgesic, antidepressant and sleeping pill intake between D0 and M3
Time frame: 3 months
Consumption of care between D0 and M3
Time frame: 3 months
Evolution between D0 and M3 of the general quality of life on the EQ-5D-5L questionnaire
Time frame: 3 months
Evolution between D0 and M3 of physical activity on the Global Physical Activity Questionnaire (GPAC).
Time frame: 3 months
Evolution of number of steps measured by the subject's smartphone collected from D0 to M3 through the Fibrepik mobile application.
Time frame: 3 months
Impression of the disease change by the patient on the Patient Global Impression of Change (PGIC) at M3
Time frame: 3 months
Impression of the disease change by the caregiver on the Clinician Global Impression of Change (CGIC) scale at M3
Time frame: 3 months
Frequency of use of the wristband on the six months of use it
Time frame: month 6 for Intervention groupe and month 9 for control group
Usability of the wristband on the modular evaluation of key Components of User Experience (meCUE) questionnaire.
Time frame: month 6 for Intervention groupe and month 9 for control group
Remedee Solution satisfaction questionnaire (questionnaire created by the sponsor)
Time frame: month 6 for Intervention groupe and month 9 for control group
Number, description, classification (serious/non-serious) of adverse effects
Time frame: 9 months
Outcomes 1 to 12 evaluated at 6 months and at 9 months.
Time frame: 9 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 6 Mar 2023.
- Derived from this study: PubMed 36064731Chipon E, Bosson JL, Minier L, Dumolard A, Vilotitch A, Crouzier D, Maindet C. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial. Trials. 2022 Sep 5;23(1):740. doi: 10.1186/s13063-022-06693-z.
- Study protocolLink 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 of Grenoble Alps
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Remedee Solution and Delayed Remedee Solution in people with Fibromyalgia, run by Remedee SA at 8 sites 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 9 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3). (time frame: 3 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 NCT05058092, which also lists 1 linked publication.
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 6 Mar 2023.