Pelvic Functional Magnetic Stimulation on Pain in Endometriosis Patients - a Prospective Non Randomised, Non-blinded Single Centre Observational Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Kantonsspital Winterthur KSW
- Enrollment
- 30
- Primary Endpoint
- Decrease of PPAF-Score before and after treatment.
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Decrease of PPAF-Score before and after treatment.
Time Frame: From enrollment to the end of tratment at end of week 7
Relief of pain measured by changes in PPAF (Pelvic pain assessment form) score before and after the treatment. 0= no pain, 10 = unbearable pain
Secondary Outcomes
- Decrease of PPAF-Score before and after treatment.(From enrollment to 3 months after completion of treatment)