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Spinal Cord Stimulation for Intractable Chronic Lower Abdominal Neuropathic Pain Caused by Endometriosis

NCT05558540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-09-28

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DEVICE

spinal cord stimulator

By continuous electrical stimulation of the nerve causing endometriosis-related pain, painful inputs to the spinal cord and brain can be reduced or even eliminated. The electrical stimulation is performed by the spinal cord stimulator (SCS).

Sponsors & Collaborators

  • Boston Scientific Group

    collaborator UNKNOWN

  • Prof. Velja Mijatovic

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-01
Completion
2024-06-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558540 on ClinicalTrials.gov