Endometriosis
Conditions
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
Interventions
DEVICEMagnetic stimulation
Magnetic stimulation using the Tesla-Chair
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease of PPAF-Score before and after treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Decrease of PPAF-Score before and after treatment. | From enrollment to 3 months after completion of treatment | Relief of pain measured by changes in PPAF (Pelvic pain assessment form) score before and after the treatment. 0= no pain, 10 = unbearable pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective experience of patients, decrease in analgetic use | From enrollment to 3 months after completion of treatment | Subjective experience of patients, decrease in analgetic use, subjective success |
Outcome results
None listed