- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gothenburg, Sweden
- Recruiting
- Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
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Contact:
- Josefin Larsson, RN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
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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.
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Conventional analgesic treatment.
Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.
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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.
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Treatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 8 weeks after randomization
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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
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8 weeks after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 16 weeks after start of TENS treatment
|
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
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16 weeks after start of TENS treatment
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Physical activity
Time Frame: 16 weeks after start of TENS treatment
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Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
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16 weeks after start of TENS treatment
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Self-assessed physical activity
Time Frame: 16 weeks after start of TENS treatment
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Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.
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16 weeks after start of TENS treatment
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Consumption of analgetics
Time Frame: 8 weeks after randomization
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Consumption of primary and secondary analgetics including opioid consumption in morphine equivalent doses
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8 weeks after randomization
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Consumption of analgetics
Time Frame: 16 weeks after start of TENS treatment
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Consumption of primary and secondary analgetics including opioid consumption in morphine equivalent doses
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16 weeks after start of TENS treatment
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Change in pain intensity
Time Frame: 8 weeks after randomization
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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, Likert scale (1= "worse," 2= "unchanged," 3= "slightly improved," 4= "much improved," 5 = "very much improved,"and 6= "completely improved").
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8 weeks after randomization
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Change in pain intensity
Time Frame: 16 weeks after start of TENS treatment
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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, Likert scale (1= "worse," 2= "unchanged," 3= "slightly improved," 4= "much improved," 5 = "very much improved,"and 6= "completely improved").
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16 weeks after start of TENS treatment
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Health Related Quality of Life (HRQL) according to SF36
Time Frame: 8 weeks after randomization
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Assessed with RAND Short Form 36 (SF36).
The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health.
The subscale scores range from 0-100, the higher score, the better health related quality of life.
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8 weeks after randomization
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Health Related Quality of Life (HRQL) according to SF36
Time Frame: 16 weeks after start of TENS treatment
|
Assessed with RAND Short Form 36 (SF36).
The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health.
The subscale scores range from 0-100, the higher score, the better health related quality of life.
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16 weeks after start of TENS treatment
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Health Related Quality of Life (HRQL) assessed with EQ-5D
Time Frame: 8 weeks after randomization
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Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
8 weeks after randomization
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Health Related Quality of Life (HRQL) assessed with EQ-5D
Time Frame: 16 weeks after start of TENS treatment
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Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
16 weeks after start of TENS treatment
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Health Related Quality of Life (HRQL) assessed with EHP 30
Time Frame: 8 weeks after randomization
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Assessed with Endometriosis Health Profile 30.
The EHP score indicate the extent of self-reported ill health on each of the 5 domains measured (Pain, Control and powerlessness, Social support, Emotional well-being, Self-image).
Each scale is standardised on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status.
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8 weeks after randomization
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Health Related Quality of Life (HRQL) assessed with EHP 30
Time Frame: 16 weeks after start of TENS treatment
|
Assessed with Endometriosis Health Profile 30.
The EHP score indicate the extent of self-reported ill health on each of the 5 domains measured (Pain, Control and powerlessness, Social support, Emotional well-being, Self-image).
Each scale is standardised on a scale of 0 - 100, where 0 indicates the best health status through to 100 worst health status.
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16 weeks after start of TENS treatment
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General Self-Efficacy Scale
Time Frame: 8 weeks after randomization
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The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life, Likert scale (1= Not at all true 2= Hardly true 3= Moderately true 4= Exactly true)
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8 weeks after randomization
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General Self-Efficacy Scale
Time Frame: 16 weeks after start of TENS treatment
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The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life, Likert scale (1= Not at all true 2= Hardly true 3= Moderately true 4= Exactly true)
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16 weeks after start of TENS treatment
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Insomnia Severity
Time Frame: 8 weeks after randomization
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Total score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
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8 weeks after randomization
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Insomnia Severity
Time Frame: 16 weeks after start of TENS treatment
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Total score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
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16 weeks after start of TENS treatment
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Days of sick-leave
Time Frame: 8 weeks after randomization
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Number of days of sick-leave
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8 weeks after randomization
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Days of sick-leave
Time Frame: 16 weeks after start of TENS treatment
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Number of days of sick-leave
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16 weeks after start of TENS treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety, depression
Time Frame: 8 weeks after randomization
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Assessed with the Hospital Anxiety and Depression (HAD) scale.
The scale consists of 14 items on a four-point response scale ranging from 0-3.
Seven items for depression and 7 items for anxiety with a score range from 0-21.
For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
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8 weeks after randomization
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Anxiety, depression
Time Frame: 16 weeks after start of TENS treatment
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Assessed with the Hospital Anxiety and Depression (HAD) scale.
The scale consists of 14 items on a four-point response scale ranging from 0-3.
Seven items for depression and 7 items for anxiety with a score range from 0-21.
For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
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16 weeks after start of TENS treatment
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Patient treatment satisfaction according to NRS
Time Frame: 8 weeks after randomization
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Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care.
Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
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8 weeks after randomization
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Patient treatment satisfaction according to NRS
Time Frame: 16 weeks after start of TENS treatment
|
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care.
Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
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16 weeks after start of TENS treatment
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Multidimensional Assessment of Interoceptive Awareness
Time Frame: 8 weeks after randomization
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The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception by self-report.
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8 weeks after randomization
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Multidimensional Assessment of Interoceptive Awareness
Time Frame: 16 weeks after start of TENS treatment
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The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception by self-report.
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16 weeks after start of TENS treatment
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Return to work
Time Frame: 8 weeks after randomization
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Number of patients who return to work part time or full time.
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8 weeks after randomization
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Return to work
Time Frame: 16 weeks after start of TENS treatment
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Number of patients who return to work part time or full time.
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16 weeks after start of TENS treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paulin Andéll, MD, Göteborgs Universitet/Västra Götalands Regionen
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 274998
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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