About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Non-invasive device-based neuromodulation
DeviceDirect 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.
Treatment groups
Trial outcomes
Primary outcomes
Evolution of Pain
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).
Secondary outcomes
Rate of Responding Patients
Patients will be classified as "responders" if they show a reduction in NVPS (Numeric Visual Pain Scale) scores equal to or greater than 30%
Evaluation of the analgesic effect maintenance
Comparison between groups of the daily Numeric Visual Pain Scale (NVPS) values, averaged over 7 days
Assessment of Overall Patient Improvement.
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Quality of Life Improvement.
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire. SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Sponsors and contacts
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