Investigating the efficacy of transcranial direct current stimulation on chronic pain management in endometriosis patients: A randomized controlled trial protocol

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AI-generated summary by claude@2026-06, 2026-06-08

This study evaluated the effectiveness of transcranial direct current stimulation on pain, fatigue, and quality of life in endometriosis patients, using algometry as the primary outcome measure.

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AI-generated deep summary by claude@2026-06, 2026-06-09

This single-center, parallel, double-blinded randomized controlled trial protocol plans to recruit 40 women aged 18–40 with deep infiltrating endometriosis and clinically significant pain, to test whether 10 consecutive daily sessions of anodal tDCS (2 mA, 20 minutes/day over motor cortex C3 with contralateral supraorbital cathode Fp2) reduce pain versus sham stimulation. Primary outcome is pain assessed with pressure algometry (pressure pain threshold and tolerance), with secondary outcomes including pain intensity, fatigue, quality of life, and patient global impression measured at baseline, after the 10th session, and at 1 and 2 months post-treatment. The protocol specifies analysis using generalized estimated equations or mixed model approaches and notes expectations that only active stimulation will reduce pain, fatigue, and quality of life, but it also states that no datasets were generated or analyzed yet because this is a protocol rather than results. This paper is centrally about endometriosis — it is a randomized controlled trial protocol evaluating tDCS for chronic pain management in endometriosis patients, with fatigue and quality-of-life secondary outcomes.

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Abstract

INTRODUCTION: Similar to chronic pain conditions, individuals with endometriosis can be affected by central sensitization syndrome (CSS), which is characterized by a loss of analgesia and central amplification of pain. Transcranial direct current stimulation (tDCS) has shown potential as an effective intervention to improve pain generated by other chronic pain conditions impacted by CSS, such as fibromyalgia and chronic pelvic issues. This study aims to evaluate the effectiveness of tDCS on pain, fatigue, and quality of life among patients affected by endometriosis. METHODS: This is a single-center, parallel, double-blinded, randomized, controlled clinical trial protocol study. We aim to recruit 40 participants affected by endometriosis (active group, n = 20; sham group, n = 20). Anodal tDCS will be delivered at an intensity of 2mA, applied over the primary motor cortex for 20 minutes per day for 10 consecutive days. There will be four assessment times: 1 week before beginning the intervention; on the 10th day following the last tDCS session; and 1 and 2 months after the last tDCS session. Pain evaluated by the algometry will be the primary outcome. Pain intensity, quality of life, fatigue, and global perception of change will be the secondary outcomes. We will calculate the effects of the active versus sham stimulation on primary and secondary outcomes by using generalized estimated equations or mixed model analysis. The effect size calculation will represent the effect measure. We expect that only the active group show reductions in pain, fatigue, and quality of life. The results of this trial will produce an important first step in providing evidence on the effectiveness of neuromodulation for the management of pain and will provide data to support new studies on tDCS. REGISTRATION: Brazilian Clinical Trials Registry (RBR-4q69573).

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Outcome instruments

EHP-30 Enzian

Condition tags

endometriosis

MeSH descriptors

Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Chronic Pain Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis

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