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 (SPINALSTIM)

November 14, 2025 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France
      • Grenoble, France, 38043
        • Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trans-spinal stimulation
Device: 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.
Active Comparator: Dorsal root ganglion stimulation
Device: 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.
Placebo Comparator: Placebo (non-stimulation (sham) mode)
The device includes a non-stimulation (sham) mode, which can be activated while still placing the electrodes and setting up the device exactly as in the active condition. In this mode, no effective electrical current is delivered, but the procedure appears identical to the real stimulation. This allows the study to maintain double-blind conditions
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
week 7 compared with baseline
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
Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).
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).
Day 50 from the beginning of tsDCS treatment compared to baseline
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.
Day 50 from the beginning of tsDCS stimulation treatment compared to baseline
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.
Day 50 from the beginning of tsDCS treatment compared to baseline
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).
Day 50 from the beginning of tsDCS treatment compared to baseline
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.
Day 50 from the beginning of tsDCS treatment compared to baseline.
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.
Day 50 from the beginning of tsDCS treatment compared to baseline.
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.
From baseline to day 50.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC24.0366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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