A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain
Unknown statusNCT05373667
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain.
Study details
- Official title
- A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain
- Conditions
- Interventions
- Procedure: Spinal Cord Stimulation (SCS)
- Sponsor
- EPC Education s.r.o.
- Collaborators
- National Hospital for Neurology and Neurosurgery
- Start date
- 2022-08-01
- Primary completion
- 2023-08-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 1\. Have a clinical diagnosis of chronic predominant pelvic pain as determined by a multidisciplinary study team. 2\. Score 13 or greater in PainDETECT questionnaire 3. 4. Have been refractory to conservative therapy for a minimum of 3 months, including assessment of at least 2 different classes of medications. 5\. Average pain intensity (over the last 7 days) of ≥ 5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (in accordance with the NICE guidelines). 6\. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator. 7\. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion. 8\. Be 18 years of age or older at the time of enrollment. 9. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. 10\. Be capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written inform consent. 11\. Be willing and capable of giving informed consent. 12. Be willing and able to comply with study-related requirements, procedures, and visits. 13\. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator Exclusion Criteria: 1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia). 2. Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury as determined by the investigator. 3. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator. 4. Significant stenosis, objective evidence of epidural scarring and/or any signs or sympt…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05373667