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Transcranial direct current stimulation to reduce chronic pelvic pain in endometriosis: Phase II Randomized Controlled Clinical Trial.

Pain Medicine 2023 March 7
BACKGROUND: It is known that various chronic pain conditions lead to maladaptive changes in the central nervous system. Endometriosis is frequently associated with chronic pelvic pain (CPP). Its sufficient treatment remains a clinical challenge. Transcranial direct current stimulation (tDCS) has been shown to be a powerful method to reduce chronic pain. Therefore, this study aimed to investigate pain reduction via anodal tDCS in patients with endometriosis and CPP.

METHODS: This clinical phase-II, placebo-controlled, randomized, parallel designed study included 36 patients with endometriosis and CPP. All patients suffered from CPP defined as ≥ 3/10 on the visual analog scale (VAS) for ≥3 month in the past six months. Anodal or placebo tDCS (18 patients per arm) was applied over the primary motor cortex for 10 days. Primary outcome measure was pressure pain threshold (objective pain measure) as well as secondary outcomes were numerical rating scale (NRS, subjective pain measure), Von-Frey-monofilaments, and disease- and pain-related questionnaires. Data was collected at baseline, after the 10-day stimulation and at a follow-up session, which took place one week after ending tDCS. Statistical analyses were performed using ANOVA and t-tests.

RESULTS: Significant decreased pain perception in both pain measurements: i) pressure pain threshold and ii) NRS were found for the active tDCS group compared to the placebo group. This proof-of-concept study shows that tDCS is a helpful/supporting pain therapy for patients with endometriosis and CPP. Moreover, further analyses revealed that one week after finishing the stimulation, pain reduction remained significantly decreased as indexed by pressure pain threshold indicating possible long-term analgesic effects.

CONCLUSION/SIGNIFICANCE: The present study provides evidence that tDCS is an effective therapy for pain reduction in endometriosis-associated CPP. The results found support the notion that CPP is developed and maintained in the central nervous system making a multimodal pain therapy necessary.

CLINICALTRIALS.GOV IDENTIFIER: NCT05231239.

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