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
Göteborg University
40 participants
Nov 12, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Conventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.
Locations(1)
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NCT05152264