Using electrical stimulation to relieve chronic pain from endometriosis
High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
This study is testing whether using electrical stimulation can help relieve chronic pain in people with endometriosis better than regular pain medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Göteborg University Academic / other |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05152264 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcutaneous electrical nerve stimulation (TENS) as an additional treatment for patients suffering from chronic pain related to endometriosis. Participants experiencing frequent and intense pain will be randomized to receive either TENS or conventional analgesic treatment for 8 weeks, while an external control group will consist of patients with less frequent pain. All participants will ultimately receive TENS treatment for a total of 16 weeks to assess both acute and long-term effects. The study aims to provide insights into optimal TENS application for pain relief in this patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with verified endometriosis and chronic pain lasting more than three months.
Not a fit: Patients with pacemakers, impaired sensation in the painful area, or serious psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective pain management option for patients with endometriosis-related chronic pain.
How similar studies have performed: While there is limited knowledge on TENS for this specific condition, similar approaches have shown promise in managing chronic pain in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg
- Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Paulin Andéll, MD — Göteborgs Universitet/Västra Götalands Regionen
- Study coordinator: Paulin Andréll, MD, PhD
- Email: paulin.andrell@gu.se
- Phone: +46-31-3438259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.