"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.

NCT06702176 | Recruiting

• 1 other identifier: 2024-A00019-38
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia, Pain

Keywords

Exopulse Mollii Suit, Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1)

  It is an 11-item scale that provides the researchers with a global assessment of the fibromyalgia syndrome, by measuring assesses Quality of Life and measures health status and functional disability and by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ ( Fibromyalgia Impact Questionnaire) scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0- 38), moderate (scores: 39-58), and severe (scores: 59-100)

  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 (11)

• Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) throughout the follow-up period (phase 2)

  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.

• Analgesic effects based on the Visual Analogue Scale (VAS) during phases 1 and 2.

  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).

• Analgesic effects based on the Brief Pain Inventory (BPI) during phases 1 and 2.

  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).

• Analgesic effects based on the Pain Catastrophizing Scale (PCS) during phases 1 and 2.

  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).

• Anti-fatigue effects according to the Visual Analogue Scale (VAS Fatigue) during phases 1 and 2.

  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).

Study Arms (2)

Experimental Condition

ACTIVE COMPARATOR

Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies.

Device: EXOPULSE MOLLII SUIT active

Control Condition

SHAM COMPARATOR

The control arm will be a sham intervention. The patients will receive a sham stimulation, for which the same Exopulse Mollii suit will be used but the control unit will be programmed to start stimulating for 1 minute then it will shut off which could enable cutaneous sensations that mimic the active condition, aiming to achieve an effective blinding integrity. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute).

Device: EXOPULSE MOLLII SUIT (sham)

Interventions

EXOPULSE MOLLII SUIT active DEVICE

Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more. EXOPULSE Mollii suit consists of transcutaneous stimulation of several muscles by means of a feeble electric current (i.e., low frequency \~20 Hz, low-intensity 2mA), aiming to reduce pain. This treatment method theoretical background primarily refers to the theory of gate control. Based on this theory, the stimulation of large proprioceptive fibers would inhibit the nociceptive information transmitted by small fibers.

Experimental Condition

EXOPULSE MOLLII SUIT (sham) DEVICE

It consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 175 µs) but for a shorter duration of time (1 minute).

Control Condition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ")

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

linical Neurophysiology department, Henri Mondor Hospital, Créteil, France

Créteil, VAL DE MARNE, 94000, France

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samar S Ayache, MD, PhD, HDR

  Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar S AYACHE, MD, PhD, HDR

CONTACT

+33 149814662; samarayache@gmail.com

Moussa A CHALAH, MD,PhD

CONTACT

moussachalah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 22, 2024
• Study Start: March 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-03

Locations

FR (1)