Evidence map›Paper›PMID 39291602›Full record

Trial reportEuropean journal of pain (London, England)2025

The effect of the EXOPULSE Mollii Suit on pain and fibromyalgia-related symptoms-A randomized sham-controlled crossover trial.

Joseph G Mattar, Moussa A Chalah, Naoufel Ouerchefani, Marc Sorel, Johan Le Guilloux, Jean-Pascal Lefaucheur, Georges N Abi Lahoud, Samar S Ayache

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of pain (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Joseph G MattarInstitut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.
Moussa A ChalahInstitut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.ORCID https://orcid.org/0000-0002-0880-8608
Naoufel OuerchefaniService de Neurochirurgie, Hôpital Foch, Suresnes, France.
Marc SorelEA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.
Johan Le GuillouxService de Neurologie, Hôpital Privé Nord Parisien, Sarcelles, France.
Jean-Pascal LefaucheurEA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.
Georges N Abi LahoudInstitut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.
Samar S AyacheInstitut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.ORCID https://orcid.org/0000-0003-0188-1957

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFibromyalgia pain and related symptoms are poorly managed by approved pharmacological and alternative interventions. This trial aimed to evaluate the effects of the EXOPULSE Mollii Suit-a multisite transcutaneous electrical nerve stimulation device-on fibromyalgia pain, fatigue, affective symptoms, disease impact, and quality of life.

methodsAdult patients with fibromyalgia were enrolled. Phase 1 implied a randomized, sham-controlled, cross-over, double-blind trial, applying daily 1 h sessions of active or sham intervention, over 2 weeks (2-week washout). In the open-label phase 2, all patients received daily active intervention for 4 weeks. Comparisons on pain, fatigue, disease impact, affective symptoms, quality of life, clinical impression, and comfort ratings were performed using Friedman, Wilcoxon signed rank, and Chi2 tests.

resultsThirty-three patients completed the study (93.9% female, mean age: 51.3 years). Pain (primary endpoint assessed via a visual analog scale) was significantly reduced after the active (pre-active: 6.9 ± 1.4, post-active: 5.9 ± 1.8, pre-sham: 6.8 ± 1.4, post-sham: 6.6 ± 1.5) versus the sham intervention (X

conclusionsThis study suggests the clinical benefits of the EXOPULSE Mollii Suit in alleviating pain and fibromyalgia-related fatigue, emotional symptoms, and disease impact. It is worth noting that the study has several limitations related to the low number of participants, the short-term analysis of effects in the first blinded and controlled phase, and the open-label nature of phase 2. Future studies with a larger cohort and longer protocol treatment are needed, to further confirm the current results, and evaluate the long-term effects of this technique. SIGNIFICANCE: Patients with fibromyalgia suffer from pain as well as fatigue, sleep impairment, emotional disturbances, and altered quality of life. Transcutaneous electrical nerve stimulation might help manage those symptoms, but the available systems are limited by the fact that they could be applied at best over two sites. This randomized controlled study is the first to apply a multi-site transcutaneous electrical nerve stimulation device, the EXOPULSE Mollii Suit, with significant effects on fibromyalgia pain and related symptoms.

Indexed as

FatigueFibromyalgiaQuality of LifeAdultAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedPainPain ManagementPain MeasurementTranscutaneous Electric Nerve StimulationTreatment Outcome

Identifiers

PMID39291602
PMCPMC11671316

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.