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AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

NCT07292337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Dr Novinth Kumar A/L Raja Ram, MBBS, MS (Gen Surg) · Department of Surgery (Urology Unit), University Malaya Medical Centre, Kuala Lumpur, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-08-30
Completion
2026-11-30

Countries

  • Malaysia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292337 on ClinicalTrials.gov