NCT05152264

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Göteborg University · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Endometriosis affects approximately one in ten women of childbearing age and may involve both acute pain related to the menstrual cycle and chronic pain. Usual analgesic therapy is often inadequate and/or involves unacceptable side effects and risks with long-term use. Transcutaneous electrical nerve stimulation (TENS) is a patient controlled treatment for pain relief with few side-effects. To date there is limited knowledge of how TENS treatment should be carried out for optimal pain relief in this patient group. The aim of the study is asses the effect of TENS as add-on treatment compared with conventional analgesic treatment in patients with endometriosis-related chronic pain. Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional treatment for 8 weeks in order 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 in chronic endometriosis-related pain. Prior to start of TENS treatment, all patients receive education on chronic endometriosis-related pain and TENS treatment. Study participants will be asked to participate in a qualitative follow-up within the study including a semi-structured individual interview (n=10-15) before intervention and a semi-structured focus group (n=9-15) interview after completion of TENS treatment.

Conditions

• Endometriosis-related Pain

Interventions

Type	Name	Description
DEVICE	Transcutaneous electrical nerve stimulation (TENS)	Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
OTHER	Conventional analgesic treatment	Conventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.

Timeline

• Start date: 2021-11-12
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2021-12-09
• Last updated: 2025-05-23

Locations

1 site across 1 country: Sweden