Clinical trial · Interventional
AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy
Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) During Transrectal Ultrasound Guided (TRUS) Prostate Biopsy: A Randomized Double-blind Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Procedural Pain Relief | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Transcutaneous Electrical Nerve Stimulation | — | UNRESOLVED | — |
| TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active AcuTENS | Device | — | UNRESOLVED |
| Placebo TENS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active AcuTENS
- 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.
- interventionNames
- Device: Active AcuTENS
- type
- PLACEBO_COMPARATOR
- label
- Placebo TENS
- 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.
- interventionNames
- Device: Placebo TENS
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTNazir 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. PMID 25246816
- RESULTOuzounidis 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. PMID 35023892