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.
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
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
Parallel
Transcutaneous electrical nerve stimulation (TENS)
DeviceTreatment with transcutaneous electrical nerve stimulation (TENS) during 16 weeks.
Conventional analgesic treatment
Other interventionConventional analgesic treatment. Conventional analgesic treatment may include no pharmacological treatment if the patient does not use any analgesics.
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
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
Physical activity
Minutes of physical activity per week at moderate and vigorous intensity physical activity (MVPA), minutes of sedentary behaviour (SED) assessed by accelerometry
Self-assessed physical activity
Minutes of physical activity per week (physical exercise and daily exercise) and minutes of sedentary behaviour per week.
Consumption of analgetics
Consumption of primary and secondary analgetics including opioid consumption in morphine equivalent doses
Anxiety, depression
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.
Anxiety, depression
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.
Patient treatment satisfaction according to NRS
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").
Patient treatment satisfaction according to NRS
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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Göteborg University
Lead sponsor
Vastra Gotaland Region
Collaborator
