AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

University of Malaya

Status: Active, not recruiting

Conditions: TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY; Transcutaneous Electrical Nerve Stimulation; Procedural Pain Relief; Prostate Cancer

Treatments: Device: Active AcuTENS; Device: Placebo TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT07292337

UMG012C-2024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

Active AcuTENS

Experimental group

Description:

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.

Treatment:

Device: Active AcuTENS

Placebo TENS

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo TENS