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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Non-invasive device-based neuromodulation

    Device

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Trans-spinal stimulationActive comparator 1 intervention
Group B: Dorsal root ganglion stimulationActive comparator 1 intervention
Group C: Placebo (non-stimulation (sham) mode)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)

Secondary outcomes

1

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%

Time frame
week 7 compared with baseline
2

Evaluation of the analgesic effect maintenance

Comparison between groups of the daily Numeric Visual Pain Scale (NVPS) values, averaged over 7 days

Time frame
Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).
3

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).

Time frame
Day 50 from the beginning of tsDCS treatment compared to baseline
4

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.

Time frame
Day 50 from the beginning of tsDCS stimulation treatment compared to baseline

Other outcomes

Sponsors and contacts

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