RecruitingNot ApplicableNCT05152264

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


Sponsor

Göteborg University

Enrollment

40 participants

Start Date

Nov 12, 2021

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Transcutaneous Electrical Nerve Stimulation (TENS) — a small device that sends gentle electrical pulses through the skin — can help reduce chronic pelvic pain caused by endometriosis. TENS is a non-invasive, drug-free pain relief method, and this study aims to see whether it can complement existing hormonal treatments for endometriosis-related pain. You may be eligible if: - You are a woman aged 18 or older - You have confirmed endometriosis (via laparoscopy or ultrasound) - You have had chronic endometriosis-related pain for more than 3 months - You are on a stable hormonal medication for endometriosis (unchanged for at least 3 months) - No gynecological surgery for endometriosis is planned in the next 7 months You may NOT be eligible if: - You do not understand or read Swedish - You have a pacemaker or other electronic implants - You have reduced sensation in the painful area - You have a terminal illness with expected survival under 12 months - You have alcohol or substance abuse issues - You have a serious untreated psychiatric illness - You are pregnant - You are using more than 90mg morphine equivalents per day Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous electrical nerve stimulation (TENS)

Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.

OTHERConventional analgesic treatment

Conventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.


Locations(1)

Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland

Gothenburg, Sweden

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NCT05152264


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