High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
RECRUITING
Gothenburg
Contact Information
Primary
Paulin Andréll, MD, PhD
paulin.andrell@gu.se
+46-31-3438259
Backup
Cecilia Ögren, RN
cecilia.ogren@vgregion.se
+46-31-3425000
Time Frame
Start Date: 2021-11-12
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
Active_comparator: TENS (transcutaneous electrical nerve stimulation)
Patients with endometriosis-related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Active_comparator: Conventional analgesic treatment
Patients with endometriosis related chronic frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) randomized to conventional analgesic treatment for 8 weeks. After 8 weeks the patients are treated with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Active_comparator: External control group
Patients with endometriosis-related pain that is not frequent or without high pain intensity (\< 4 according to Numeric Rating Scale, NRS) constitute an external control group. The patients are treated with transcutaneous electrical nerve stimulation as add-on treatment in addition to conventional analgesic treatment. Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Vastra Gotaland Region
Leads: Göteborg University

This content was sourced from clinicaltrials.gov