Clinical trial protocol comparing transcutaneous electrical stimulation (actiTENS) with low-dose TENS in women with chronic pain from pelvic endometriosis

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.