Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07237165

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Pelvic Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France, Créteil, France

Loading trial locations.

About this study

Conduct of study:

Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via Redcap. Only this physician will have the knowledge of the group allocated to the patient.

Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.

Treatment sessions: after the baseline, sessions of neurostimulation will begin for 5 weeks.

After the end of neurostimulation sessions, patients will be followed for 2 weeks.

Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Evolution of Pain

    Time frame: 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).

Secondary outcomes

  1. Rate of Responding Patients

    Time frame: week 7 compared with baseline

    Patients will be classified as "responders" if they show a reduction in NVPS (Numeric Visual Pain Scale) scores equal to or greater than 30%

  2. Evaluation of the analgesic effect maintenance

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

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

  3. Assessment of Overall Patient Improvement.

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

    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).

  4. Quality of Life Improvement.

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

    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.

  5. Evolution of Anxiety and Depressive Traits.

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

    Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.

  6. Evolution of Symptomatological Profiles of Neuropathic Pain.

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

    Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).

  7. Sympathetic Autonomic System Injury and Small Fiber Neuropathy.

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

    Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.

  8. Autonomous System Assessement.

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

    Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.

  9. Evolution of the use of analgesic treatments.

    Time frame: From baseline to day 50.

    Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SPINALSTIM

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.