Chronic Pelvic Pain
Conditions
Keywords
Chronic pelvic pain, Non-invasive spinal cord neuromodulation, Trans-spinal direct current stimulation (tsDCS), Trans-spinal stimulation, Dorsal root ganglion stimulation (DRGS)
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.
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
DEVICENon-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.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the analgesic effect maintenance | 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 |
| Assessment of Overall Patient Improvement. | 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). |
| Quality of Life Improvement. | 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. |
| Evolution of Anxiety and Depressive Traits. | 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. |
| Rate of Responding Patients | 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% |
| Sympathetic Autonomic System Injury and Small Fiber Neuropathy. | 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. |
| Autonomous System Assessement. | 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. |
| Evolution of the use of analgesic treatments. | From baseline to day 50. | Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary. |
| Evolution of Symptomatological Profiles of Neuropathic Pain. | 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). |
Countries
France
Outcome results
None listed