Spinal Cord Stimulation for intractable chronic lower abdominal neuropathic pain caused by endometriosis
- Conditions
- Chronische neuropathische pijnchronic painendometriosis
- Registration Number
- NL-OMON50815
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
- Patients with endometriosis/ adenomyosis confirmed at surgery and without
options for further surgical treatment.
- Premenopausal woman aged >= 18 years
- Patients with at least one of the endometriosis related pain symptoms:
dysmenorrhea, pelvic pain or dyspareunia.
- 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
- Neurologic exam without marked motor deficit.
- Meets all the inclusion criteria for the implantation of a neurostimulation
system as typically utilized in the study center.
- 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
- Female subject of childbearing potential is pregnant/nursing or plans to
become pregnant during the course of the study
- The presence of any malignancy
- BMI >=35
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean pain intensity and patients global impression of change at 6 months </p><br>
- Secondary Outcome Measures
Name Time Method