Study Results
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Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2024-01-08
2025-05-24
Brief Summary
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Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.
Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)
Study subjects will participate in:
A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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EXOPULSE Mollii Suit Stimulation Active.
This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.
EXOPULSE Mollii Suit Stimulation
We designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
EXOPULSE Mollii Suit Stimulation Sham.
This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes
EXOPULSE Mollii Suit Stimulation
We designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
Interventions
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EXOPULSE Mollii Suit Stimulation
We designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
Eligibility Criteria
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Inclusion Criteria
* Patients should be able to understand verbal instructions.
Exclusion Criteria
* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
* Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
* Any change in the pharmacological therapy in the last three months
* Introduction of a medical device other than Exopulse Mollii suit during the study period
* Patient under juridical protection
18 Years
75 Years
ALL
No
Sponsors
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Sheikh Shakhbout Medical City
OTHER
Responsible Party
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Naji Joseph Riachi
Principal Investigator
Locations
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SSMC
Abu Dhabi, , United Arab Emirates
Countries
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References
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Other Identifiers
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EXOFIB2
Identifier Type: -
Identifier Source: org_study_id
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