Original Title: Efectividad y seguridad de técnicas bioeléctricas de estimulación en fibromialgia: revisión sistemática

Authors' objectives: To assess the effectiveness and safety of TMS, repetitive transcranial magnetic stimulation (rTMS), tDCS, high-definition transcranial direct current stimulation (HD-tDCS), PEMF, and transcranial pulsed low-frequency magnetic field (t-PEMF) stimulation, in the treatment of fibromyalgia.

Authors' results and conclusions: Results Seven SRs (with 35 RCTs in total) were included: two SRs with MA evaluated the effectiveness of TMS and five SRs reported about the effectiveness of tDCS (three of them with MA). SRs on PEMF were not included. Additionally, 17 RCTs were included: two on rTMS, six on tDCS (two of them evaluated home self-administered tDCS) and eight studies on PEMF (three of them evaluated t-PEMF). In 15 of these RCTs a sham group was included as a comparator and, in some cases, an additional control group was added (treatment as usual, pharmacological treatment and no intervention). The assessment of the general confidence in the results of the included SRs was critically low for most of the SRs, except one SR that obtained moderate confidence and another SR obtained low confidence. Overall, three RCTs additional scored an overall assessment of low risk of bias, seven studies were rated as unclear risk of bias, and the remaining seven studies were rated as high risk of bias. A MA was carried out with the additional RCTs on PEMF for the variables pain intensity, severity of symptoms, general health-related quality of life and fibromyalgia-related quality of life. Conclusions • The available scientific evidence on the effectiveness and safety of rTMS, tDCS and PEMF, as well as their evaluated variants, suggests that they could improve pain and quality of life, in terms of disease impact, in people with fibromyalgia. However, high-quality studies are needed in order to demonstrate its clinical relevance. • The results are not consistent regarding the possible benefit of these techniques on other symptoms such as anxiety, depression or fatigue. • While the techniques evaluated appear to be safe, mild adverse effects related to the area of stimulation may occur. • For each of the techniques evaluated, the application protocol that could produce greater pain relief in people with fibromyalgia would consist of: low-frequency rTMS in to the right dorsolateral prefrontal cortex; tDCS in the left primary motor cortex or in the occipital nerve. In the case of PEMF, the available evidence shows that shorter interventions show better results.

Authors' methods: A systematic review (SR) of the available literature on the effectiveness and safety of the bioelectrical stimulation techniques described above was carried out, according to the methodology developed by the Cochrane Collaboration and presented following the guidelines of the PRISMA statement. The selected studies were SRs with or without metaanalysis (MA) and randomized controlled trials (RCTs) published after the included SRs. The SRs were evaluated with the AMSTAR-2 and the risk of bias of the RCTs was evaluated using the RoB-II tool of the Cochrane Collaboration. A narrative synthesis of the results offered by the SRs included and of the RCTs published after SRs was made. When SRs with MA were not identified for any of the techniques evaluated, an MA was carried out for each outcome measure whenever data was available. The outcome evaluated were pain (intensity, interference, number of tender points, pain threshold), fatigue, severity of symptoms, quality of life, anxiety, and depression.

Project Status: Completed

Year Published: 2023

URL for published report: https://sescs.es/wp-content/uploads/2015/09/SESCS_Fibromialgia_DEF_NIPO.pdf?x68814

Requestor: Ministry of Health

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es