Clinical trial · Interventional
Efficacy Of Acupuncture in Pain and Anxiety During Transperineal Prostate Biopsy: A Prospective, Randomized, Sham-Controlled Trial
NCT06987071CI-TRIAL-00122538completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. Participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. The primary outcome is pain, measured using the Visual Analog Scale (VAS), while secondary outcomes include anxiety, additional analgesic use, patient satisfaction, and adverse events.
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 |
|---|---|---|---|
| Acupuncture Analgesia | — | UNRESOLVED | — |
| Pain Management | — | UNRESOLVED | — |
| Prostate Biopsy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| sham acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acupuncture
- description
- Participants receive acupuncture at specific points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, 30 minutes before the biopsy, alongside standard local anesthesia.
- interventionNames
- Procedure: Acupuncture
- type
- SHAM_COMPARATOR
- label
- Sham Acupuncture
- description
- Participants receive superficial needle insertion at non-acupuncture points without stimulation, 30 minutes before the biopsy, alongside standard local anesthesia.
- interventionNames
- Procedure: sham acupuncture
Primary outcomes (1)
- measure
- Pain Score
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Indicated for transperineal prostate biopsy (e.g., elevated PSA, abnormal digital rectal exam). * Willing and able to provide written informed consent. Exclusion Criteria: * Known allergy or contraindication to acupuncture (e.g., bleeding disorder, needle phobia). * Requirement for sedation or general anesthesia. * Previous experience with acupuncture treatment. * Severe psychiatric disorders or diagnosed anxiety disorder.
References
Publications (4)
- RESULTHong A, Hemmingway S, Wetherell D, Dias B, Zargar H. Outpatient transperineal prostate biopsy under local anaesthesia is safe, well tolerated and feasible. ANZ J Surg. 2022 Jun;92(6):1480-1485. doi: 10.1111/ans.17593. Epub 2022 Mar 10. PMID 35274426
- RESULTYang J, Xiong X, Wei Q, Yang L. Acupuncture: a promising adjuvant strategy for pain management among the patients with prostate cancer. BJU Int. 2024 Oct;134(4):664-665. doi: 10.1111/bju.16467. Epub 2024 Jul 17. No abstract available. PMID 39019800
- RESULTLin FX, Chen Y, Xu ZP. Enhancing perioperative pain management: the integrative potential of acupuncture in urological surgery. BJU Int. 2024 Oct;134(4):667-668. doi: 10.1111/bju.16503. Epub 2024 Aug 6. No abstract available. PMID 39106982
- RESULTWang J, Lei Y, Bao B, Yu X, Dai H, Chen F, Li H, Wang B. Acupuncture for pain caused by prostate cancer: Protocol for a systematic review. Medicine (Baltimore). 2019 Jan;98(2):e13954. doi: 10.1097/MD.0000000000013954. PMID 30633174