Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain

NCT05152264 | Recruiting

• 1 other identifier: 274998
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis-related Pain

Keywords

Endometriosis; Chronic pain; Transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to endometriosis-related chronic pain

  8 weeks after randomization

Secondary Outcomes (19)

• Pain intensity

  16 weeks after start of TENS treatment

• Physical activity

  16 weeks after start of TENS treatment

• Self-assessed physical activity

  16 weeks after start of TENS treatment

• Consumption of analgetics

  8 weeks after randomization

• Consumption of analgetics

  16 weeks after start of TENS treatment

Other Outcomes (8)

• Anxiety, depression

  8 weeks after randomization

• Anxiety, depression

  16 weeks after start of TENS treatment

• Patient treatment satisfaction according to NRS

  8 weeks after randomization

Study Arms (3)

TENS (transcutaneous electrical nerve stimulation)

ACTIVE COMPARATOR

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.

Device: Transcutaneous electrical nerve stimulation (TENS)

Conventional analgesic treatment

ACTIVE COMPARATOR

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.

Other: Conventional analgesic treatment

External control group

ACTIVE COMPARATOR

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.

Device: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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

External control group; TENS (transcutaneous electrical nerve stimulation)

Conventional analgesic treatment OTHER

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

Conventional analgesic treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

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

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Endometriosis; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Paulin Andéll, MD

  Göteborgs Universitet/Västra Götalands Regionen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulin Andréll, MD, PhD

CONTACT

+46-31-3438259; paulin.andrell@gu.se

Cecilia Ögren, RN

CONTACT

+46-31-3425000; cecilia.ogren@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 analgesic 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.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

SE (1)