Clinical trial protocol comparing transcutaneous electrical stimulation (actiTENS) with low-dose TENS in women with chronic pain from pelvic endometriosis
Year: 2026
Type: article
Abstract: Endometriosis causes pelvic pain, particularly during menstruation, but it is also a chronic pain syndrome. Transcutaneous electrical nerve stimulation (TENS) is one of the most frequently prescribed non-pharmacological interventions for pain. We have therefore decided to investigate the efficacy of TENS (actiTENS) for relieving endometriosis-related pain. We will perform a prospective, randomized, multicenter, controlled, crossover study followed by an open-label phase at 27 sites in France. The study population will consist of 208 women with chronic endometriosis pelvic pain. The women will be randomized, in a 1:1 ratio, to either the actiTENS or low-dose TENS for at least 60 min twice daily. The first phase of the study will be a crossover trial with two three-month periods. An open-label trial will then follow. The primary outcome will be the change in average pain over the last 28 days of the three-month treatment period concerned relative to the baseline for the period. The secondary outcomes will include quality of life, EHP30 scores, global impression of change, analgesic use, current pain intensity, impact of pain, pain relief, and device utilization. This study will determine the efficacy of TENS for relieving endometriosis-associated pain and provide support for treatment decisions for endometriosis-associated pain. Clinical trial registration:www.clinicaltrials.gov identifier is NCT07317037. Endometriosis is a long-term condition that can cause ongoing pain and make everyday life difficult. Transcutaneous electrical nerve stimulation (TENS) is a treatment that uses gentle electrical signals applied through the skin to help relieve pain, without medication. This study will investigate whether a TENS device called actiTENS can help reduce long-term pelvic pain in women with endometriosis. It will compare actiTENS with a similar treatment using very low electrical stimulation. The study will include 208 women from 27 hospitals and medical centers in France. Each woman will receive both treatments, but in a different order. She will use one treatment for 3 months, then have a 4-week break without stimulation before using the other treatment for another 3 months. Women will be asked to use the device for at least 1 hour, twice a day. The main aim is to find out which treatment is more effective in reducing pain. Women will be asked to report their pain levels, particularly during the last 4 weeks of each treatment period, and these will be compared with their pain levels before treatment. The researchers will also look at whether the treatments improve quality of life and daily activities, reduce the need for pain medication, and provide meaningful pain relief. They will also assess how often women use the device, how comfortable it is, and how they feel about their overall improvement. After completing both treatments, all women will be offered three additional months of actiTENS treatment. This final part of the study will help researchers better understand how women use the device and which women may benefit most from it. The overall goal is to find out whether actiTENS could offer women with endometriosis a useful, drug-free option for managing chronic pelvic pain.
Source: Figshare
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225806116
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