AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

December 17, 2025 updated by: Harshini Mahendran, University of Malaya

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • University of Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient consented for first time TRUS prostate biopsy.
  2. Patient aged 18 years and above.

Exclusion Criteria:

  1. Patient with previous experience of TRUS biopsy
  2. Patient with pacemakers or automatic cardiac defibrillator implant or implant in the upper limb
  3. Patient with cutaneous skin breaks on application sites (e.g wound, burn scar)
  4. Patient diagnosed to have epilepsy or impaired mental state or anxiety disorder
  5. Patient with known allergy to acupuncture patch or lidocaine spray

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active AcuTENS
Participants receive active transcutaneous electrical nerve stimulation applied to selected acupuncture points before and during TRUS-guided prostate biopsy, in addition to standard periprostatic nerve block.
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.
Placebo Comparator: Placebo TENS
Participants receive a identical TENS device with a placebo setting and no therapeutic electrical output, applied to the same acupuncture points before and during TRUS-guided prostate biopsy, in addition to standard periprostatic nerve block.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy pain relief of application of Acu-TENS in TRUS prostate biopsy
Time Frame: VAS scores will be recorded in real time at the moment of maximal discomfort during: Insertion of the transrectal ultrasound probe Injection of periprostatic local anaesthesia Prostate biopsy sampling Time Frame: Immediately during the procedure

Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated pain measurement tool ranging from 0 to 10, where:

0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.
VAS scores will be recorded in real time at the moment of maximal discomfort during: Insertion of the transrectal ultrasound probe Injection of periprostatic local anaesthesia Prostate biopsy sampling Time Frame: Immediately during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate anxiety levels of subjects undergoing TRUS biopsy with application of Acu-TENS
Time Frame: STAI scores will be measured: 1. Before the biopsy 2. Immediately after completion of the biopsy Time Frame: Pre-procedure and immediately post-procedure

Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), a validated self-reported questionnaire consisting of two subscales:

State Anxiety (STAI-S): measures situational anxiety at a specific time Trait Anxiety (STAI-T): measures baseline anxiety tendency

Each subscale score ranges from 20 to 80, with:

Lower scores indicating lower anxiety Higher scores indicating greater anxiety
STAI scores will be measured: 1. Before the biopsy 2. Immediately after completion of the biopsy Time Frame: Pre-procedure and immediately post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

August 30, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Estimated)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMG012C-2024 (Other Grant/Funding Number: Mahmood Merican Research Grant, University of Malaya)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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