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 | Not Yet Recruiting

• 1 other identifier: 38RC24.0366
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Pelvic Pain

Keywords

Chronic pelvic pain; Non-invasive spinal cord neuromodulation; Trans-spinal direct current stimulation (tsDCS); Trans-spinal stimulation; Dorsal root ganglion stimulation (DRGS)

Outcome Measures

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).

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

Secondary Outcomes (9)

• Rate of Responding Patients

  week 7 compared with baseline

• Evaluation of the analgesic effect maintenance

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

• Assessment of Overall Patient Improvement.

  Day 50 from the beginning of tsDCS treatment compared to baseline

• Quality of Life Improvement.

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

• Evolution of Anxiety and Depressive Traits.

  Day 50 from the beginning of tsDCS treatment compared to baseline

Study Arms (3)

Trans-spinal stimulation

ACTIVE COMPARATOR

Device: Non-invasive device-based neuromodulation

Dorsal root ganglion stimulation

ACTIVE COMPARATOR

Device: Non-invasive device-based neuromodulation

Placebo (non-stimulation (sham) mode)

PLACEBO COMPARATOR

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

Interventions

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.

Dorsal root ganglion stimulation; Placebo (non-stimulation (sham) mode); Trans-spinal stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

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

Créteil, France

Location

Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)

Grenoble, 38043, France

Location

Related Publications (19)

• Hodaj H, Payen JF, Lefaucheur JP. A Case of Long-Term Treatment of Chronic Pain Syndrome by Anodal tDCS of the Motor Cortex, Previously Resistant to High-Frequency rTMS and Implanted Spinal Cord Stimulation. Brain Stimul. 2016 Jul-Aug;9(4):618-20. doi: 10.1016/j.brs.2016.02.008. Epub 2016 Mar 22. No abstract available.

  PMID: 27101725 RESULT

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 RESULT

• Hodaj H, Payen JF, Mick G, Vercueil L, Hodaj E, Dumolard A, Noelle B, Delon-Martin C, Lefaucheur JP. Long-term prophylactic efficacy of transcranial direct current stimulation in chronic migraine. A randomised, patient-assessor blinded, sham-controlled trial. Brain Stimul. 2022 Mar-Apr;15(2):441-453. doi: 10.1016/j.brs.2022.02.012. Epub 2022 Feb 25.

  PMID: 35219923 RESULT

• Hodaj H, Payen JF, Hodaj E, Dumolard A, Maindet C, Cracowski JL, Delon-Martin C, Lefaucheur JP. Long-term treatment of chronic orofacial, pudendal, and central neuropathic limb pain with repetitive transcranial magnetic stimulation of the motor cortex. Clin Neurophysiol. 2020 Jul;131(7):1423-1432. doi: 10.1016/j.clinph.2020.03.022. Epub 2020 Apr 10.

  PMID: 32387962 RESULT

• Hodaj H, Payen JF, Dumolard A, Delon-Martin C, Lefaucheur JP. Treatment of pudendal neuralgia by high-frequency rTMS of the medial wall of motor cortex bilaterally using an angled figure-of-eight coil. Brain Stimul. 2020 Sep-Oct;13(5):1412-1413. doi: 10.1016/j.brs.2020.07.009. Epub 2020 Jul 23. No abstract available.

  PMID: 32712341 RESULT

• Hodaj H, Payen JF, Hodaj E, Sorel M, Dumolard A, Vercueil L, Delon-Martin C, Lefaucheur JP. Long-term analgesic effect of trans-spinal direct current stimulation compared to non-invasive motor cortex stimulation in complex regional pain syndrome. Brain Commun. 2023 Jul 1;5(4):fcad191. doi: 10.1093/braincomms/fcad191. eCollection 2023.

  PMID: 37545548 RESULT

• Guidetti M, Ferrucci R, Vergari M, Aglieco G, Naci A, Versace S, Pacheco-Barrios K, Giannoni-Luza S, Barbieri S, Priori A, Bocci T. Effects of Transcutaneous Spinal Direct Current Stimulation (tsDCS) in Patients With Chronic Pain: A Clinical and Neurophysiological Study. Front Neurol. 2021 Sep 6;12:695910. doi: 10.3389/fneur.2021.695910. eCollection 2021.

  PMID: 34552550 RESULT

• Rahman MA, Tharu NS, Gustin SM, Zheng YP, Alam M. Trans-Spinal Electrical Stimulation Therapy for Functional Rehabilitation after Spinal Cord Injury: Review. J Clin Med. 2022 Mar 11;11(6):1550. doi: 10.3390/jcm11061550.

  PMID: 35329875 RESULT

• Fregni F, El-Hagrassy MM, Pacheco-Barrios K, Carvalho S, Leite J, Simis M, Brunelin J, Nakamura-Palacios EM, Marangolo P, Venkatasubramanian G, San-Juan D, Caumo W, Bikson M, Brunoni AR; Neuromodulation Center Working Group. Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders. Int J Neuropsychopharmacol. 2021 Apr 21;24(4):256-313. doi: 10.1093/ijnp/pyaa051.

  PMID: 32710772 RESULT

• Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518.

  PMID: 29952860 RESULT

• Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14.

  PMID: 21576030 RESULT

• Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.

  PMID: 18786856 RESULT

• Priori A, Ciocca M, Parazzini M, Vergari M, Ferrucci R. Transcranial cerebellar direct current stimulation and transcutaneous spinal cord direct current stimulation as innovative tools for neuroscientists. J Physiol. 2014 Aug 15;592(16):3345-69. doi: 10.1113/jphysiol.2013.270280. Epub 2014 Jun 6.

  PMID: 24907311 RESULT

• Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A. Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.

  PMID: 22783208 RESULT

• Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

  PMID: 11723286 RESULT

• Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.

  PMID: 14580622 RESULT

• Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012.

  PMID: 23293607 RESULT

• Margueritte F. Algies pelviennes chroniques : prévalence et caractéristiques associées dans la cohorte Constances. Revue d'Epidémiologie et de Santé Publique 2016, Doi : 10.1016/j.respe.2016.01.094

  RESULT

• Rahman A, Reato D, Arlotti M, Gasca F, Datta A, Parra LC, Bikson M. Cellular effects of acute direct current stimulation: somatic and synaptic terminal effects. J Physiol. 2013 May 15;591(10):2563-78. doi: 10.1113/jphysiol.2012.247171. Epub 2013 Mar 11.

  PMID: 23478132 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)