Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis
Unknown statusNot applicableNCT05558540
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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)
Endometriosis is a chronic, inflammatory disease where endometrium-like tissue is present outside the uterus. Nerve cells in the proximity of this tissue express cytokine receptors causing a signaling cascade. This results in active cross-talk between endometriosis and nerves, causing pelvic pain. Other symptoms associated with endometriosis are cyclical such as dysmenorrhea and dysuria, and non-cyclical such as dyspareunia. Despite adequate disease management, women can still experience endometriosis-related pain. A recent development proven to be efficient in treatment of neuropathic pain, is Spinal Cord Stimulation (SCS). It is also thought to be effective in the treatment of visceral pain. Several studies found Spinal Cord Stimulation (SCS) to be effective in the reduction of endometriosis-related pelvic pain. However, scientific evidence on the efficacy of SCS in visceral pain is limited.
Study details
- Official title
- Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis
- Conditions
- Interventions
- Sponsor
- Prof. Velja Mijatovic
- Collaborators
- Boston Scientific Group
- Organization
- Amsterdam UMC, location VUmc
- Start date
- 2022-10-01
- Primary completion
- 2023-12-01
- Sex
- Female
- Age range
- from 18 Years to 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Premenopausal woman aged ≥ 18 years * Patients with endometriosis/ adenomyosis confirmed at surgery macroscopically and without options for further surgical treatment. * Patients with at least one of the endometriosis related pain symptoms: dysmenorrhea, pelvic pain or dyspareunia. With a mean pain NRS of at least 5 (scale 0-10). * The pain complaints are therapy resistant (including hormonal, medical and/or surgical options). * Refractory pain; before neuromodulation patient has tried: Paracetamol, NSAIDs, Anti neuropathic pain therapy, TENS. * The patient meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. * Neurologic exam without marked motor deficit. * Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation * Subject is able and willing to comply with the follow-up schedule and protocol * Subject is able to provide written informed consent Exclusion Criteria: * Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study. * The presence of malignancy * Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump * Subject is unable to operate the device * Previous Neurostimulation therapy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05558540