Clinical trial NCT06702176: "Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.
Official title: "Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia, Pain
Keywords: Exopulse Mollii Suit, Fibromyalgia
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators designed a trial that includes two phases: (i) phase 1 which consists of a 2-week intervention of Exopulse Mollii suit "active" versus "sham", separated by a 2-week washout period to prevent any carry-over effects; (ii) phase 2 that will be carried out two weeks following the end of phase 1. Phase 2 will last 6 months (24 weeks: 7 sessions per week) with a monthly assessment aiming to explore the long-term effects of this method on fibromyalgia.

Summary:

* Phase 1: randomized sham-controlled crossover study (active vs. sham condition/ assessment every two weeks )
* Phase 2: Open-label (active condition, 6 months/monthly assessment)
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. A previous pilot trial on fibromyalgia (EXOFIB-1 study) was conducted to evaluate the effects of Exopulse Mollii suit on fibromyalgia has showed beneficial and promising results. The intervention significantly alleviated pain, reduced fatigue, decreased physical and psychosocial impact of the disease, and improved the quality of life of patients with fibromyalgia. However, the observed effect sizes were small to medium. The investigators believe that a stimulation duration extended to six months would yield more positive outcomes and higher effect magnitude.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least three months
* Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance

Exclusion Criteria:

* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitoring 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 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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")

Primary outcomes:
measure: Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1)
timeFrame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit 1(Day 0) ,Visit 2 (Day 15), Visit 3( Day 30) and Visit4 (Day 45)
Secondary outcomes:
measure: Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) throughout the follow-up period (phase 2)
timeFrame: This will be assessed during the phase 2 visits (6 months of using the EXOPULSE Mollii suit). The visits will take place monthly, starting from visit 5 and throughout visits 6, 7, 8, 9, 10 and 11.
measure: Analgesic effects based on the Visual Analogue Scale (VAS) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Analgesic effects based on the Brief Pain Inventory (BPI) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Analgesic effects based on the Pain Catastrophizing Scale (PCS) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Anti-fatigue effects according to the Visual Analogue Scale (VAS Fatigue) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Mood changes as per the Hospital Anxiety and Depression Scale (HADS) (phases 1 and 2)
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Quality of life using the Short Form 36 Health Survey (SF-36) during phases 1 and 2
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Sleep changes using the Leeds Sleep Evaluation Questionnaire (LSEQ) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Sleep changes using the Pittsburgh Sleep Quality Index (PSQI) during phases 1 and 2.
timeFrame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
measure: Evaluation of overall improvement using the CGI (Clinical Global Impression)
timeFrame: This will be assessed at visit 2 (day 15), visit 4 (day 45), and monthly from the second phase of 6 months of treatment (V5, V6, V7, V8, V9, V10, and V11), as the CGI is designed to be applied after the interventions.
measure: Evaluation of patient's blinding to the type of stimulation in the crossover trial
timeFrame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.
Other outcomes:
Locations:
city: Créteil
country: France
facility: linical Neurophysiology department, Henri Mondor Hospital, Créteil, France
state: Val de Marne
Study officials:
affiliation: Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
name: Samar S Ayache, MD, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References: