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Starting soon Not applicable

Evaluation of the Analgesic Effect of Direct Current Stimulation in the Treatment of Pelvic Pain, Comparing Three Groups: Trans-spinal Stimulation, Ganglionic Stimulation, and Placebo. A Randomized Double-blind Study

NCT07237165 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2025-11-19

Condition(s) studied

Chronic Pelvic Pain

Investigational drug(s) / intervention(s)

Non-invasive device-based neuromodulation

Non-invasive device-based neuromodulation: Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.

Study summary

The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups:

* Trans-spinal tsDCS stimulation,
* Ganglionic tsDCS stimulation,
* Placebo (sham) tsDCS stimulation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Patient aged 18 to 85 years, suffering from pelvic pain for more than one year (excluding musculoskeletal causes). * Patient with stable ongoing medication (analgesic or otherwise) for at least one month. * Patient for whom lack of response to conventional treatments has led the pain specialist or referring physician to consider non-pharmacological therapeutic options. * Patient reporting a pain intensity score \>3 on the Numeric Visual Pain Scale (NVPS) during pre-screening. * Patient affiliated with the national health insurance system or an equivalent scheme. * Patient who has provided written informed consent. Exclusion Criteria: * History of drug addiction. * History of psychiatric disorders likely to interfere with the proper conduct of the study. * Patient with skin lesions in the lumbar region. * Person unable to understand the study protocol. * Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code, corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, or under legal protection. * Subject currently in the exclusion period of another clinical trial

Primary outcome measure(s)

  • Evolution of Pain — Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
    Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Pain Scale (VNPS): The patient will raise his pain level on a follow-up diary each day. The VNPS average will be calculated for each week. The VNS is a 10-point scale, ranging from 0 (worse) to 10 (better).

Trial sites (2)

FacilityCityRegionStatus
Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France Créteil France
Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes) Grenoble France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07237165 on ClinicalTrials.gov ↗ ← All trials in France