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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Evolution of Pain [Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)]

Secondary outcome measures (9)

• Rate of Responding Patients [Time frame: 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).]
• Assessment of Overall Patient Improvement. [Time frame: 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]
• Evolution of Anxiety and Depressive Traits. [Time frame: 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]
• Sympathetic Autonomic System Injury and Small Fiber Neuropathy. [Time frame: 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.]
• Evolution of the use of analgesic treatments. [Time frame: From baseline to day 50.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

France · 2 centers

• Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpit — Créteil
• Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes) — Grenoble

Publications

• 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
• 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; PMID 27866120
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07237165 · 38RC24.0366

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗