AcuTENS as an Analgesic and Anxiolytic Adjunct During Transrectal Ultrasound (TRUS) Guided Prostate Biopsy: A Randomized Placebo-Controlled Trial
摘要
Pain and anxiety are major concerns during transrectal ultrasound (TRUS)–guided prostate biopsy despite usage of periprostatic nerve block (PPNB). AcuTENS, a form of acupuncture-based transcutaneous electrical nerve stimulation applied over acupuncture points, may enhance multimodal analgesia and anxiolysis. This study aimed to assess the analgesic and anxiolytic effects of AcuTENS compared to a placebo control group during TRUS-guided biopsy compared with placebo stimulation. A randomized, placebo-controlled trial was conducted at University Malaya Medical Centre between May and December 2024 where participants and the outcome assessor were blinded to group allocation. Fifty-six men scheduled for TRUS-guided biopsy were randomized to receive AcuTENS targeting acupuncture points (intervention, n = 28) or placebo stimulation (n = 28). All patients received standard PPNB. Pain was measured using a 0–10 Numeric Rating Scale (NRS) at probe insertion, PPNB injection, biopsy needle insertion, and overall. Anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S) pre- and post-procedure. AcuTENS significantly reduced overall procedural pain compared with placebo (2.7 SD 1.3 vs. 3.9 SD 1.2; p < 0.001). Pain during PPNB injection (2.3 SD 1.7 vs. 3.6 SD 1.6; p = 0.003) and biopsy needle insertion (2.0 SD 1.6 vs. 3.4 SD 1.8; p = 0.002) was also lower, while pain at probe insertion did not differ (4.3 SD 2.2 vs. 4.5 SD 1.6; p = 0.336). ANCOVA analysis showed that AcuTENS reduced post-procedure anxiety compared to placebo (F(1,53) = 28.04,p < 0.001),effect size (Partial η2 = 0.35) regardless of the initial anxiety levels. No adverse effects were reported. AcuTENS is a safe, non-invasive adjunct that significantly reduces procedural pain and anxiety during TRUS-guided prostate biopsy when used with standard PPNB, supporting its routine clinical use.
Trial Registration: ClinicalTrials.gov: NCT07292337; retrospectively registered 17 December 2025.