Back to resultsEvaluation of the Effectiveness of the Remedee Solution in Fibromyalgia (Fibrepik)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate Remedee Solution
Delayed Remedee Solution
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring pain, sleep disturbances, millimeter waves
Eligibility Criteria
Inclusion Criteria:
- 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),
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- University Hospital of Grenoble Alps
- CHU de Montpellier
- Cabinet libéral Dr. Lorenzi-Pernot
- Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris
- CHU de Rouen
- Hôpital Foch
- Centre Hospitalier de Valenciennes
- Médipôle hôpital mutualiste
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
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)
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
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.
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
Evolution of number of steps measured by the subject's smartphone collected from D0 to M3 through the Fibrepik mobile application.
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.
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.
Frequency of use of the wristband on the six months of use it
Analyses of log file of wristband
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).
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
Number, description, classification (serious/non-serious) of adverse effects
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05058092
Brief Title
Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia
Acronym
Fibrepik
Official Title
The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Remedee SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
pain, sleep disturbances, millimeter waves
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization in two groups of type: Immediate Solution vs. Delayed Solution
Masking
Investigator
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Immediate Remedee Solution
Intervention Description
D0 to M3: Remedee Solution + medical care
M3 to M6: Remedee Solution without personalized support + medical care
M6 to M9: medical care only
Intervention Type
Device
Intervention Name(s)
Delayed Remedee Solution
Intervention Description
D0 to M3: medical care only
M3 to M6: Remedee Solution + medical care
M6 to M9: Remedee Solution without personalized support + medical care
Primary Outcome Measure Information:
Title
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).
Description
A decrease in FIQ score ≥ 14% is considered clinically meaningful (Bennett et al., 2009)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evolution of the quality of sleep between D0 and M3 on the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Description
The score of the PSQI questionnaire is between 0 and 21. The higher score (21) means the worse quality of sleep.
Time Frame
3 months
Title
Evolution between D0 and M3 of the average pain score over the week on a Visual Analogic Scale (VAS).
Description
The score of the VAS is beetween 0 and 10. The higher score (10) means the worse pain.
Time Frame
3 months
Title
Evolution between D0 and M3 of anxiety and depression on the Hospital and Anxiety Depression scale (HAD).
Description
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.
Time Frame
3 months
Title
Evolution between D0 and M3 of fatigue between the two groups on the Multidimensional Fatigue Inventory questionnaire (MFI20)
Description
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.
Time Frame
3 months
Title
Evolution of analgesic, antidepressant and sleeping pill intake between D0 and M3
Description
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.
Time Frame
3 months
Title
Consumption of care between D0 and M3
Description
number of:
care (procedures, medical consultations, hospitalizations),
complementary care (acupuncture, osteopath, naturopath, etc.),
psycho-behavioral therapies,
complementary treatments (phytotherapy, homeopathy, food supplements).
Time Frame
3 months
Title
Evolution between D0 and M3 of the general quality of life on the EQ-5D-5L questionnaire
Description
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.
Time Frame
3 months
Title
Evolution between D0 and M3 of physical activity on the Global Physical Activity Questionnaire (GPAC).
Description
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
Time Frame
3 months
Title
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
Title
Impression of the disease change by the patient on the Patient Global Impression of Change (PGIC) at M3
Description
The PGIC scale is a 7 point scale depicting a patient's rating of overall improvement.
Time Frame
3 months
Title
Impression of the disease change by the caregiver on the Clinician Global Impression of Change (CGIC) scale at M3
Description
The CGIC scale is a 7 point scale depicting a patient's rating of overall improvement.
Time Frame
3 months
Title
Frequency of use of the wristband on the six months of use it
Description
Analyses of log file of wristband
Time Frame
month 6 for Intervention groupe and month 9 for control group
Title
Usability of the wristband on the modular evaluation of key Components of User Experience (meCUE) questionnaire.
Description
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).
Time Frame
month 6 for Intervention groupe and month 9 for control group
Title
Remedee Solution satisfaction questionnaire (questionnaire created by the sponsor)
Description
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
Time Frame
month 6 for Intervention groupe and month 9 for control group
Title
Number, description, classification (serious/non-serious) of adverse effects
Time Frame
9 months
Title
Outcomes 1 to 12 evaluated at 6 months and at 9 months.
Description
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
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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),
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.
Exclusion Criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline MAINDET, MD
Organizational Affiliation
University Hospital of Grenoble Alps
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble Alps
City
Grenoble
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
Cabinet libéral Dr. Lorenzi-Pernot
City
Mornant
Country
France
Facility Name
Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris
City
Paris
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
Facility Name
Hôpital Foch
City
Suresnes
Country
France
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
Country
France
Facility Name
Médipôle hôpital mutualiste
City
Villeurbanne
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
36064731
Citation
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.
Results Reference
derived
Links:
URL
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06693-z
Description
Study protocol
Learn more about this trial
Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia
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