NCT05152264 Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
| NCT ID | NCT05152264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Endometriosis-related Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-11-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-11-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Paulin Andéll, MD
PRINCIPAL INVESTIGATOR
Göteborgs Universitet/Västra Götalands Regionen
Frequently Asked Questions
Who can join the NCT05152264 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Endometriosis-related Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05152264 currently recruiting?
Yes, NCT05152264 is actively recruiting participants. Contact the research team at paulin.andrell@gu.se for enrollment information.
Where is the NCT05152264 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT05152264 clinical trial?
NCT05152264 is sponsored by Göteborg University. The principal investigator is Paulin Andéll, MD at Göteborgs Universitet/Västra Götalands Regionen. The trial plans to enroll 40 participants.