NCT05152264Recruiting
Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 29 Nov 2021
- Start date
- 12 Nov 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- Göteborg University
- Diseases
- Endometriosis
- NCT number
- NCT05152264
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 12 Nov 2021 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with pacemaker and/or ICD or other electronic implants
Other illness
- Malignant disease with an expected survival \<12 months
- Serious untreated psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
Other
- Patient with inability to understand and use written and spoken Swedish
- Patient with impaired sensation over the painful area
- Alcohol or substance abuse
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.