Chronische neuropathische pijn chronic pain endometriosis
Conditions
Interventions
Implantation of a spinal cord stimulator with accompanying epidural leads
(Boston Spectra Wavewriter System).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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 - 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean pain intensity and patients global impression of change at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean pain: NRS pain score (3 times a day for 3 days) at baseline and 3-6 and 12 months post implant. • The number (percentage) of subjects who achieve a reduction in the pain intensity of at least 50%(substantial change) or 30% (moderately important change) at 6 months compared to baseline.(12) • Patient*s global impression of change(PGIC): dichotomous (better or improved versus not better or improved) at 3-6- and 12-months post implant. • Change in quality of life: EHP 30 & SF36 at baseline and at 6- and 12-months post implant. • Change in fatigue: EHP 30 at baseline and 6- and 12-months post implant • Pain Catastrophizing assessed with the PCS at baseline, 6- and 12-months post implant. • Central Sensitization Inventory at baseline and 6- and 12-months post implant. • Pain medication use at baseline 3- 6- and 12-months post implant • Lost working days: iPCQ Productivity Cost Questionnaire at baseline and at 6 months post implant • Number of patients with a failed trial SCS • Complications and side effects: 3, 6, and 12 months post implant. | — |
Countries
Netherlands
Outcome results
None listed