Efficacy Of Acupuncture in Pain and Anxiety During Transperineal Prostate Biopsy: A Prospective, Randomized, Sham-Controlled Trial

NCT06987071 | Completed

• 1 other identifier: 357843951
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer; Pain Management; Acupuncture Analgesia; Prostate Biopsy

Keywords

acupuncture; prostate cancer; transperineal prostat biopsy; acupuncture anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Visual Analog Scale (VAS), a 0-10 scale where 0 represents no pain and 10 represents the worst pain imaginable.

  Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.

Secondary Outcomes (3)

• Anxiety Level

  before and after 30 minutes of operation

• Additional Analgesic Use

  after biopsy in 8 hours

• Adverse events

  peri operative

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

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.

Procedure: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Participants receive superficial needle insertion at non-acupuncture points without stimulation, 30 minutes before the biopsy, alongside standard local anesthesia.

Procedure: sham acupuncture

Interventions

Acupuncture PROCEDURE

Insertion of sterile, single-use needles at specific acupuncture points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, administered 30 minutes before the biopsy by a licensed acupuncturist.

Acupuncture

sham acupuncture PROCEDURE

Superficial needle insertion at non-acupuncture points without stimulation, administered 30 minutes before the biopsy, mimicking the acupuncture procedure without therapeutic intent.

Sham Acupuncture

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for transperineal prostate biopsy (e.g., elevated PSA, abnormal digital rectal exam).
• Willing and able to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

İstanbul Başakşehir Çam ve sakura City Hospita

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Hong 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 RESULT

• Yang 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 RESULT

• Lin 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 RESULT

• Wang 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a randomized, single-blind, parallel-group trial. Participants are randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture 30 minutes prior to transperineal prostate biopsy. Both groups receive standard local anesthesia. Randomization is performed using a computer-generated sequence, and outcome assessors are blinded to group assignments.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 23, 2025
• Study Start: July 15, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 20, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

TU (1)