Actively Recruiting
High Frequency, High Intensity Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain - a Randomized Controlled Trial
Led by Göteborg University · Updated on 2025-05-23
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
Göteborg University
Lead Sponsor
V
Vastra Gotaland Region
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of transcutaneous electrical nerve stimulation (TENS) as an additional treatment compared with conventional pain medication in women with chronic pain related to endometriosis. Endometriosis affects about one in ten women of childbearing age and can cause both acute and chronic pain, often not fully relieved by usual pain treatments. The study focuses on patients with frequent, high-intensity pain and also includes an external control group with less frequent or less intense pain, to assess both short- and long-term effects of TENS. Participants with frequent, high-intensity pain (score 64 on a pain scale) are randomly assigned to receive either TENS plus conventional treatment or conventional treatment alone for 8 weeks to compare immediate effects. After this, all participants receive TENS treatment for a total of 16 weeks. Those in the external control group, who have less frequent or lower intensity pain, receive TENS alongside their usual care for 16 weeks. Before starting TENS, all patients get education about chronic pain and TENS use. Some will also participate in interviews before and after treatment to share their experiences. Throughout the study, participants will have their pain intensity measured at 8 weeks after randomization and at 16 weeks after starting TENS treatment. Other assessments include physical activity levels, medication use, quality of life, sleep quality, self-efficacy, and days of sick leave. These evaluations involve questionnaires and scales such as the Numeric Rating Scale for pain, SF36, EQ-5D, and EHP 30 for quality of life. The study monitors patients over 16 weeks to understand both the immediate and sustained effects of TENS on endometriosis-related chronic pain.
CONDITIONS
Brief Title
Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Consents to participation in the study
- Verified endometriosis by laparoscopy or ultrasound
- Chronic endometriosis-related pain lasting more than 3 months and available for TENS treatment
- Stable endometriosis-specific hormonal drug therapy unchanged for the last 3 months
- No planned gynecological surgery for endometriosis during the next 7 months
You will not qualify if you...
- Inability to understand and use written and spoken Swedish
- Pacemaker, ICD, or other electronic implants
- Impaired sensation over the painful area
- Malignant disease with expected survival less than 12 months
- Alcohol or substance abuse
- Serious untreated psychiatric illness or psychological condition
- Participation in another intervention study affecting outcome measures
- Use of more than 90 morphine equivalents per day
- Current use of electro-acupuncture
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 16 weeks depending on treatment group
Participants with frequent and intense endometriosis-related pain receive transcutaneous electrical nerve stimulation (TENS) treatment as an add-on or conventional analgesic treatment for pain relief. Some participants initially receive conventional analgesic treatment for 8 weeks before starting TENS for 16 weeks. Participants with less frequent or less intense pain receive TENS treatment for 16 weeks.
Multiple visits during treatment period
Duration - Up to 16 weeks after start of TENS treatment
Participants are observed for long-term effects of TENS treatment on pain intensity, physical activity, analgesic use, and quality of life after treatment completion.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Pain Centre, Department of Anaesthesiology and Intensive Care Medicine Östra, Sahlgrenska University Hospital, Region Västra Götaland
Gothenburg, Sweden
Actively Recruiting
Research Team
P
Paulin Andréll, MD, PhD
C
Cecilia Ögren, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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