NCT07292337

AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) During Transrectal Ultrasound Guided (TRUS) Prostate Biopsy: A Randomized Double-blind Placebo-controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether transcutaneous electrical nerve stimulation applied at specific acupuncture points (AcuTENS) can reduce pain and anxiety during transrectal ultrasound-guided prostate biopsy for participants suspected of prostate cancer. Many patients experience significant discomfort despite the use of periprostatic nerve block (PPNB). The aim of this study is to determine whether AcuTENS provides additional pain relief or anxiety reduction beyond standard analgesia. The findings may help identify a simple, low-risk adjunct that can improve patient comfort during prostate biopsy. AcuTENS is a non-invasive technique that delivers mild electrical stimulation through the skin, targeting acupuncture points believed to modulate pain perception. In this randomized, double-blind, placebo-controlled trial, participants are assigned to receive either active AcuTENS or a placebo TENS device that produces no therapeutic stimulation . All participants with receive routine care, including PPNB, according to institutional protocol. Pain scores, anxiety levels, vital signs, and patient satisfaction are recorded before, during, and after the biopsy.

Detailed description

Transrectal ultrasound-guided prostate biopsy is the standard diagnostic procedure for suspected prostate cancer. Despite routine analgesic strategies such as periprostatic nerve block, many patients continue to experience moderate pain and procedure-related anxiety. AcuTENS, a form of transcutaneous electrical nerve stimulation applied to acupuncture points, has shown potential benefits in chronic pain conditions, osteoarthritis, and procedural discomfort in small-scale studies. Its proposed mechanism involves activation of peripheral nerve fibers, endogenous opioid pathways, and autonomic modulation, leading to reduced pain perception and improved relaxation. However, high-quality randomized controlled data for its use during prostate biopsy are limited. This study is a randomized, double-blind, placebo-controlled clinical trial conducted at University Malaya Medical Centre. The trial consists of two arms: 1. Active AcuTENS: Electrical stimulation applied to predetermined acupuncture points before and during the biopsy. 2. Placebo TENS: Identical device with no therapeutic electrical output. An initial pilot phase involving 10 patients demonstrated that AcuTENS was feasible, safe, and potentially beneficial. This informed the development of the current definitive trial, which includes 53 participants. All participants undergo the standard TRUS-guided prostate biopsy with local anesthesia using PPNB. Pain (VAS), anxiety (standardized scales), heart rate, blood pressure, and patient satisfaction are assessed at predefined time points. The primary outcome is assessment of pain during insertion of ultrasound probe, injection of local anaesthesia and pain during collection of biopsy. Secondary outcomes include anxiety reduction, hemodynamic stability, satisfaction scores, and any adverse effects related to TENS use. This investigation aims to determine whether AcuTENS offers meaningful improvement in patient comfort during prostate biopsy. If effective, it could be incorporated into routine practice as a simple, safe, and affordable adjunct to existing analgesic measures.

Conditions

• Prostate Cancer
• Procedural Pain Relief
• TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY
• Transcutaneous Electrical Nerve Stimulation

Interventions

Type	Name	Description
DEVICE	Active AcuTENS	Electrical stimulation delivered via surface electrodes placed on predefined acupuncture points. Stimulation is applied before and during the biopsy using a device capable of therapeutic current output.
DEVICE	Placebo TENS	An identical TENS device set to a placebo setting with no active electrical output. Electrodes are applied to the same acupuncture points, with no therapeutic stimulation.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-08-30
• Completion: 2026-11-30
• First posted: 2025-12-18
• Last updated: 2025-12-24

Locations

1 site across 1 country: Malaysia