Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
Recruiting · NCT05152264 · Interventional (participants receive a specific treatment) · Lead sponsor: Göteborg University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity will be randomized to additional treatment with TENS or conventional treatment for 8 weeks to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis-related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment.
Who can take part
Inclusion criteria
- Age ≥18 years
- Consents to participation in the study
- Verified endometriosis (by laparoscopy or ultrasound).
- Chronic endometriosis-related pain (\> 3 months), available for TENS treatment
- Functioning, stable endometriosis-specific hormonal drug therapy. The endometriosis-specific drug therapy must be unchanged for the last 3 months and no gynecological surgical procedures for the treatment of endometriosis are planned during the next 7 months (during study participation). The endometriosis-specific drug therapy does not refer to analgesic therapy for symptom relief of endometriosis-related pain.
Exclusion criteria
- Patient with inability to understand and use written and spoken Swedish
- Patient with pacemaker and/or ICD or other electronic implants
- Patient with impaired sensation over the painful area
- Malignant disease with an expected survival \<12 months
- Alcohol or substance abuse
- Serious untreated psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
- Participating in another intervention study with possible impact on current study outcome measures
- Patient who is using \>90 morphine equivalents/day
- Patient who is electro-acupuncture
- Pregnancy
Where it is running
1 location listed.
- Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland - Gothenburg, Sweden