Clinical trial NCT06987071: Acupuncture for Analgesia in Transperineal Prostate Biopsy: A Randomized Controlled Trial
Official title: Acupuncture for Analgesia in Transperineal Prostate Biopsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Pain Management
Acupuncture Analgesia
Prostate Biopsy
Keywords: acupuncture
prostate cancer
transperineal prostat biopsy
acupuncture anesthesia
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 110
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Transperineal prostate biopsy is a standard diagnostic procedure for prostate cancer, often associated with pain and anxiety. Although local anesthesia is commonly used, it may not fully alleviate discomfort, and systemic medications can introduce side effects. Acupuncture, a traditional Chinese medicine technique, has demonstrated potential in managing procedural pain and reducing anxiety across various clinical settings. However, its specific efficacy for transperineal prostate biopsy remains underexplored.

This study aims to determine whether acupuncture, administered before the biopsy, can reduce pain, decrease anxiety, and enhance patient satisfaction compared to a sham procedure. Employing a randomized, single-blind design, the trial seeks to minimize bias and generate robust evidence regarding acupuncture's benefits in this context.

Participants will be randomly assigned to either the acupuncture group or the sham acupuncture group, with both receiving standard local anesthesia to ensure ethical care. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points, and anxiety will be measured with the State-Trait Anxiety Inventory (STAI). Additional outcomes include the use of supplementary analgesics, patient satisfaction, and any adverse events associated with the interventions.

The study's findings could inform clinical practice by introducing a complementary, non-pharmacological option for pain management during transperineal prostate biopsy, potentially improving patient comfort and reducing reliance on systemic medications.

The study protocol has been approved by the Institutional Review Board (IRB) of our hospital, and all participants will provide written informed consent prior to enrollment. Data will be collected and monitored by an independent data manager to ensure accuracy and patient safety.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Score
timeFrame: Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.
Secondary outcomes:
measure: Anxiety Level
timeFrame: before and after 30 minutes of operation
measure: Additional Analgesic Use
timeFrame: after biopsy in 8 hours
measure: Adverse events
timeFrame: peri operative
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Başakşehir Çam ve sakura City Hospita
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.