AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy
NCT ID: NCT07292337
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
53 participants
INTERVENTIONAL
2024-12-01
2026-11-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
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 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.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
2. Patient aged 18 years and above.
Exclusion Criteria
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
18 Years
MALE
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Harshini Mahendran
Research Team member
Principal Investigators
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Dr Novinth Kumar A/L Raja Ram, MBBS, MS (Gen Surg)
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery (Urology Unit), University Malaya Medical Centre, Kuala Lumpur, Malaysia
Locations
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University of Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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References
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Nazir B. Pain during transrectal ultrasound-guided prostate biopsy and the role of periprostatic nerve block: what radiologists should know. Korean J Radiol. 2014 Sep-Oct;15(5):543-53. doi: 10.3348/kjr.2014.15.5.543. Epub 2014 Sep 12.
Ouzounidis X, Moysidis K, Kalinderis N, Papanikolaou D, Koukourikis P, Papaefstathiou E, Hatzimouratidis K. Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial. Hippokratia. 2020 Oct-Dec;24(4):166-172.
Related Links
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Pain as the 5th Vital Sign Guideline
Other Identifiers
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UMG012C-2024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UMG012C-2024
Identifier Type: -
Identifier Source: org_study_id