REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FIBROMYALGIA: AN INTERNATIONAL MULTICENTER CONTROLL

Background & Aims

Background: Noninvasive repetitive transcranial magnetic stimulation (rTMS) has been shown to control neuropathic pain when delivered to the primary motor cortex (M1). It has also shown to restore maladaptive cortical excitability and lead to analgesic effects in people with fibromyalgia (PwF) in two pioneer monocenter studies. The present double-blind sham-controlled study assessed whether induction sessions, followed by spaced maintenance sessions could improve pain and related symptoms in PwF in a long-term, multicenter, international trial. Aim: To evaluate the long-term effects of rTMS on PwF.

Methods

Women (n=101, out of 245 screened) were randomized into active (n=52) and sham (n= 49) arms. Patients from the active arm received active rTMS (10Hz, 3000 pulses, figure of eight coil, postero-anterior current direction). Sham rTMS was performed with identical coils lacking electromagnetic fields. Interventions were divided into three phases: induction (1 x day for 5 days), maintenance (1x week) and extended maintenance (fortnight stimulations) for 16 weeks. The main outcome was the number of responders (reduction of ?50% in pain intensity at week 8 compared to baseline), measured on a 11-point numerical rating scale (NRS) ranging from 0 to 10. Secondary outcomes included the fibromyalgia impact questionnaire (FIQ), global impression of change (GIC), mood (hospital anxiety and depression scale (HADS), and the brief pain inventory (BPI). Adverse events, and blinding were assessed by a standardized questionnaire. (registration: NCT03658694).

Results

Pre-planned single-level Bayesian models showed 99.4% probability of achieving 50% reduction in pain at week 8 in the active arm compared to sham (estimated difference: 1.11 (0.232; 2.09)), odds ratio (OR): 3.04 (1.26,8.06). Frequentist analyses confirmed these findings (responders = 40.4%, non-responders=18.4%; p=0.028), NNT=4.54, effect size: 0.49). Additionally, by week 16, there was a notable reduction in effect: 34.2% (OR: 0.815(0.313;2.1). At week 8 the probability of active rTMS being superior to sham stimulation on in secondary outcomes were: BPI-pain severity index: 92.6% (Estimate difference: -1.21, 0.192); BPI-interference: 65.8% (Estimate difference: -1.02, 0.693), FIQ: 80.1% (Estimate difference: -2.95(-9.72; 3.83)); HADS-anxiety: 67.7% (Estimate difference: -0.392 (-2.14, 1.3)), depression: 32.1% (Estimate difference: 0.407 (-1.28, 2.12)). Blinding was effective and safe.

Conclusions

This international multicentric study suggests that rTMS targeting the M1 has significant analgesic effects in PwF. Effects weaned during the extended maintenance phase with treatment administered every 2 weeks.

References

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Presenting Author

Valquíria Aparecida da Silva

Poster Authors

Valquiria Silva

PhD

Hospital das clinicas da faculdade de São Paulo

Lead Author

REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FIBROMYALGIA: AN INTERNATIONAL MULTICENTER CONTROLL

Background & Aims

Methods

Results

Conclusions

References

Presenting Author

Valquíria Aparecida da Silva

Poster Authors

Valquiria Silva

Abrahao Baptista

Koichi Hosomi

Alessandra Santos da Fonseca

ADRIANA Carneiro

André R. Brunoni

Paulo Carrilho

Catarina C. Lins

Gabriel T. Kubota

Ana Mércia B. L. Fernandes

Lucas Macedo

Kátia M. Silva

Frédérique Poindessous-jazat

Adriana Baltar

Clarice Tanaka

Manoel J. Teixeira

Nobuhiko Mori

Kenji Miki

Didier Bouhassira

Nadine Attal

Daniel de Andrade

Topics

IASP 2024 World Congress on Pain