Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-12

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Endometriosis-related Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Conventional analgesic treatment

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type DEVICE

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

Interventions

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Transcutaneous electrical nerve stimulation (TENS)

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

Intervention Type DEVICE

Conventional analgesic treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No