Neuromodulation : journal of the International Neuromodulation Society · 2025
Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study.
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van Haaps Annelotte P, Kallewaard Jan Willem, Bieze Matthanja, Erwteman Micha, Nap Annemiek, Hollmann Markus W, Schreurs Anneke M F, Mijatovic Velja
Аннотация
OBJECTIVES: Endometriosis, an estrogen-dependent chronic inflammatory disease, can cause visceral pain. Owing to its chronic nature, treatment can be challenging and insufficient in reducing all symptoms despite adequate management. Spinal-cord stimulation (SCS), a well-established treatment, could be used in treating intractable, endometriosis-related visceral pain and thereby improve quality of life (QoL).
MATERIALS AND METHODS: A prospective, unblinded feasibility study (NCT05558540) was conducted between May 2022 and January 2025. We included patients with endometriosis reporting pain scores ≥ 5 (numeric rating scale [NRS], 0-10) who are experiencing dysmenorrhea, dyspareunia, and/or chronic pelvic pain (CPP), with a clear neurologic examination and approval for SCS during multidisciplinary consultation. All participants received a Boston device with two 16-contact Infinion CX leads placed between T8 and T12, with a 14-day trial period before permanent implantation. Inclusion stopped when seven participants experienced ≥ 50% symptom improvement at 6-month follow-up. Pain symptom reduction (in NRS) was used as the primary outcome. Secondary outcomes included change in QoL (NRS; Endometriosis Health Profile-30 [EHP-30]), Short Fatigue Questionnaire, Pain Catastrophizing Scale, and analgesic use. Data were collected through questionnaires and during examination visits.
RESULTS: Nine participants underwent SCS, and after a successful trial period, all had a permanent implantation. Improvement in general and worst pain, and of dysmenorrhea, CPP, dysuria, and dyschezia was observed when comparing baseline with different follow-up moments. Improvement was found in self-reported QoL scores and in all but one of the EHP-30 core domains. All participants but one were able to reduce their analgesics. One participant underwent device explantation owing to lack of effect at 12-month follow-up.
CONCLUSIONS: SCS reduced intractable, endometriosis-related visceral pain and improved QoL. Because no sample size calculation could be performed, the results should be interpreted with caution. We emphasize the need to further study the application of SCS for endometriosis by performing randomized studies, which also includes a cost-analysis.
CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05558540.
MATERIALS AND METHODS: A prospective, unblinded feasibility study (NCT05558540) was conducted between May 2022 and January 2025. We included patients with endometriosis reporting pain scores ≥ 5 (numeric rating scale [NRS], 0-10) who are experiencing dysmenorrhea, dyspareunia, and/or chronic pelvic pain (CPP), with a clear neurologic examination and approval for SCS during multidisciplinary consultation. All participants received a Boston device with two 16-contact Infinion CX leads placed between T8 and T12, with a 14-day trial period before permanent implantation. Inclusion stopped when seven participants experienced ≥ 50% symptom improvement at 6-month follow-up. Pain symptom reduction (in NRS) was used as the primary outcome. Secondary outcomes included change in QoL (NRS; Endometriosis Health Profile-30 [EHP-30]), Short Fatigue Questionnaire, Pain Catastrophizing Scale, and analgesic use. Data were collected through questionnaires and during examination visits.
RESULTS: Nine participants underwent SCS, and after a successful trial period, all had a permanent implantation. Improvement in general and worst pain, and of dysmenorrhea, CPP, dysuria, and dyschezia was observed when comparing baseline with different follow-up moments. Improvement was found in self-reported QoL scores and in all but one of the EHP-30 core domains. All participants but one were able to reduce their analgesics. One participant underwent device explantation owing to lack of effect at 12-month follow-up.
CONCLUSIONS: SCS reduced intractable, endometriosis-related visceral pain and improved QoL. Because no sample size calculation could be performed, the results should be interpreted with caution. We emphasize the need to further study the application of SCS for endometriosis by performing randomized studies, which also includes a cost-analysis.
CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05558540.