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NCT Number: NCT07292337

AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

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.

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Key information

Conditions

Prostate Cancer Agnosia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Procedural Pain Relief Prostatic Diseases Prostatic Neoplasms Signs and Symptoms TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY Transcutaneous Electrical Nerve Stimulation Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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:

  • Active AcuTENS: Electrical stimulation applied to predetermined acupuncture points before and during the biopsy.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Active AcuTENS

Device

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 TENS

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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