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)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Chronic Pelvic Pain

Treatments: Device: Non-invasive device-based neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07237165

38RC24.0366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Trans-spinal stimulation

Active Comparator group

Treatment:

Device: Non-invasive device-based neuromodulation

Dorsal root ganglion stimulation

Active Comparator group

Treatment:

Device: Non-invasive device-based neuromodulation

Placebo (non-stimulation (sham) mode)

Placebo Comparator group

Description:

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

Treatment:

Device: Non-invasive device-based neuromodulation