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

Medipol University

Status: Completed

Conditions: Prostate Biopsy; Pain Management; Acupuncture Analgesia; Prostate Cancer

Treatments: Procedure: sham acupuncture; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06987071

357843951

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Acupuncture

Active Comparator group

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.

Treatment:

Procedure: Acupuncture

Sham Acupuncture

Sham Comparator group

Description:

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

Treatment:

Procedure: sham acupuncture