NL-OMON50815
Recruiting
Not Applicable
Spinal Cord Stimulation for intractable chronic lower abdominal neuropathic pain caused by endometriosis - Spinal Cord Stimulation for Endometriosis pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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