Impact of Magnetic Stimulation on Pain in Endometriosis Patients

NCT ID: NCT07265687

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-04-30

Brief Summary

Many women with endometriosis still experience pain despite surgical and medical treatment. Over-the-counter painkillers are usually helpful in alleviating this pain. But for some patients, these medications eventually stop working. Pain then dominates their daily life. In this study, we are investigating the effects of magnetic stimulation using the "Tesla chair" and whether it can alleviate their pain

Detailed Description

Patients who are diagnosed with CPP and hypertonic pelvic floor as assessed in gynaecological exam will be asked to participate. Before start of the Tesla chair treatment VAS Score by PPAF will be assessed. After 6 treatments (after 3 weeks an intermediate doctor's consultation will rule out aggravation of CPP by treatment and if possible the next cycle of 6 treatments will be scheduled. After completion of 12 treatments the VAS Score will be reassessed and treatments' success evaluated in a doctor's consultation. We plan to re-evaluate sustaining success after 3 months after treatments completion

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tesla-Chair

Group Type: EXPERIMENTAL

Magnetic stimulation

Intervention Type: DEVICE

Magnetic stimulation using the Tesla-Chair

Interventions

Magnetic stimulation

Magnetic stimulation using the Tesla-Chair

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has been informed about study
• Age ≥ 18 years
• Premenopausal
• histologically or laparoscopically or MRI confirmed endometriosis
• CPP (cyclical pelvic pain VAS ≥ 5)
• Pelvic floor hypertonicity
• Written informed consent
• sufficient German speaking
• Current endocrine therapy for >= 3 months

Exclusion Criteria

• Contraindications according manufactureres manual Tesla Chair
• Pregnancy or desire to become pregnant within the next 8 weeks
• Pelvic organ prolapses
• Genital infections
• Menstruation
• active malignancy, Malignant tumors
• Severe neurological diseases
• Cardiac arrhythmia
• Active internal medical devices e.g. cardiac pacemakers, medication, pumps etc.
• Ferromagnetic implants at or near the site of stimulation
• Recent surgery at the site of stimulation
• Thrombosis or thrombophlebitis
• Epilepsy or suspected epilepsy
• Acute stages of kidney stones
• Gastrointestinal and internal disease at the site of stimulation
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
• Previous enrolment into the current investigation
• Enrolment of the Sponsor or PI, their family members, employees and other dependent persons
• No endocrine therapy or use of endocrine therapy for < 3 months
• active inflammatory diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Winterthur KSW

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-D0011

Identifier Type: OTHER

Identifier Source: secondary_id

Tesla-Endom

Identifier Type: -

Identifier Source: org_study_id