Efficacy and safety of transcutaneous electrical nerve stimulation in the treatment of moderate-to-severe itch after burns on limbs (TE-ITCH): protocol for a multicentre, randomised, placebo-controlled clinical trial.

Abstract

Itching is a common and distressing clinical manifestation following burns, which severely impairs patient quality of life. Current pharmacotherapy for post-burn pruritus is limited by low efficacy and frequent side effects. Transcutaneous electrical nerve stimulation (TENS), a non-invasive neuromodulation technique, is widely used for analgesia and exhibits a favourable safety and tolerability profile. Although itch and pain are both nociceptive sensations, they constitute distinct sensory modalities. This clinical trial aims to evaluate the efficacy and safety of TENS for treating moderate to severe post-burn itching. This multicentre, randomised, placebo-controlled clinical trial intends to recruit 382 patients with moderate-to-severe itching (the Worst Itch Numeric Rating Scale (WINRS) score of ≥4) after burns from multiple burn centres across China for TENS treatment. The recruitment process began in April 2025 and is expected to be concluded in October 2027. Eligible patients will be randomly assigned in a 1:1 ratio to receive either TENS stimulation (experimental group) or placebo stimulation (control group). The intervention will be administered once daily for 30 min across seven consecutive days. The primary outcome is the 7-day itch improvement rate, defined as the proportion of patients who achieved a reduction of at least 50% in the WINRS score on day 7 of the intervention, assessed on day 8, compared with their prerandomisation baseline. Secondary outcomes include the severity of itching, neuropathic symptoms and signs, sleep disturbance, quality of life, scar severity and safety. Exploratory endpoints consist of neuroimaging markers and scar function parameters. A physician and the patient will complete all assessments during the intervention phase and at the follow-up visit on day 14. Ethical approval for this multicentre study was granted by the leading ethics committee, the Ethics Committee of the First Affiliated Hospital of Army Medical University (KY2024217). All authors are affiliated with the First Affiliated Hospital of Army Medical University. ChiCTR2500099822.