Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
RecruitingNot applicableNCT05152264
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
- Conditions
- Endometriosis-related Pain
- Interventions
- Device: Transcutaneous electrical nerve stimulation (TENS)
- Other: Conventional analgesic treatment
- Sponsor
- Göteborg University
- Collaborators
- Vastra Gotaland Region
- Start date
- 2021-11-12
- Primary completion
- 2027-12
- Sex
- Female
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05152264