Electroacupuncture in the Treatment of Patients Undergoing Transperineal Prostate Biopsy Under Local Anesthesia

NCT07069049 | Not Yet Recruiting

• 1 other identifier: 2024-1592-175-01
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prostate biopsy is the gold standard for the diagnosis of prostate cancer, and transperineal puncture is a common approach. It has the advantages of no bowel preparation and relative safety. At present, transperineal puncture is often performed under local anesthesia, but there are still clinical problems such as pain and anxiety for patients. Electroacupuncture is often used as an auxiliary means of local anesthesia in China, which has the advantages of analgesia and anti-anxiety. This study was conducted to evaluate the efficacy and safety of electroacupuncture combined with local anesthesia in transperineal needle biopsy.

Conditions

Prostate Cancer

Keywords

electroacupuncture; Prostate Needle biopsy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The maximum pain level

  Use Numerical Rating Scale to Assess the maximum pain level during the operation,0-100mm,higher scores mean a worse outcome.

  The end of the operation

Secondary Outcomes (4)

• Area under the curve for cumulative pain scores

  1h、6h、24h after completion of surgery

• Visual Analogue Scale for anxiety

  At the beginning of operation and at the completion of operation

• Incidence of rescue analgesia and total number of rescue analgesia

  At the completion of operation

• Blood pressure

  At the completion of the operation and 20 min before the start of the operation

Study Arms (2)

electroacupunture

EXPERIMENTAL

In the EA group, on the basis of routine local lidocaine anesthesia, EA stimulation was performed 20min before the operation and the needles were retained until the completion of the operation. Sterile acupuncture needles (Huatuo brand, specification: 0.25mm\*40mm) were applied to Hegu (Li4), Neiguan (PC 6), Guanyuan (CV 4) and Sanyinjiao (SP 6) by twidling, rotating, lifting and thrusting for 30 seconds. After getting qi (a feeling of acid, numbness, weight and swelling), the electronic acupuncture instrument (SDZ-II type, Huatuo brand) was connected, and the continuous wave was 50HZ. The current intensity was 1-5mA (preferably as much as the patient could tolerate without pain). Acupuncture was performed by a fixed-practice acupuncturist with at least 5 years of experience. Acupuncturists were trained in acupoints and acupuncture manipulation before the trial, and intervention completion was recorded.

Other: electroacupuncture

Sham-electroacupunture

SHAM COMPARATOR

The intervention process of patients in the control group was the same as that of the experimental group, but the acupuncture site was located 3mm away from the acupoints of the experimental group, and the acupuncture method was shallow acupuncture, only 1-4mm through the skin. After the sham acupuncture, the lifting and thrusting twisling method was not performed to avoid qi gain. The needles were removed if the patient experienced any adverse events related to acupuncture. Sham acupuncture was performed by a fixed-practice acupuncturist with at least 5 years of experience. Acupuncturists were trained in sham acupoints and acupuncture manipulation before the trial, and intervention completion was recorded.

Other: Sham-electroacupunture

Interventions

electroacupuncture OTHER

Sterile acupuncture needles (Huatuo brand, specification: 0.25mm\*40mm) were applied to Hegu (Li4), Neiguan (PC 6), Guanyuan (CV 4) and Sanyinjiao (SP 6) by twidling, rotating, lifting and thrusting for 30 seconds. After getting qi (a feeling of acid, numbness, weight and swelling), the electronic acupuncture instrument (SDZ-II type, Huatuo brand) was connected, and the continuous wave was 50HZ. The current intensity was 1-5mA (preferably as much as the patient could tolerate without pain).

electroacupunture

Sham-electroacupunture OTHER

Sham electroacupuncture was applied at the non-meridian and non-acupoint sites 3mm apart from the acupoints in the experimental group. The acupuncture method was shallow acupuncture, only 1-4mm through the skin.

Sham-electroacupunture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (1) To voluntarily participate in the study, I or his legal representative signed a written informed consent.
• (2) 18-80 years old (including 18 and 80 years old), male. (3) in accordance with the indication of prostate biopsy.

You may not qualify if:

• (1) in the stage of acute genitourinary infection or fever. (2) patients with chronic pain (such as bone metastasis of prostate cancer, knee osteoarthritis, scapulohumeral periarthritis, etc.) or acute pain (tonsillitis, acute lumbar sprain, etc.) before surgery.
• (3) Continuous use of anti-anxiety or analgesic drugs (use of anti-anxiety drugs or analgesics for more than 1 week in the past 3 months).
• (4) in the decompensated stage of cardiac insufficiency; A disease with a tendency to bleed heavily.
• (5) severe immunosuppression. (6) hypertension, diabetes and other complications were poorly controlled or unstable.
• (7) complicated with severe internal or external hemorrhoids, perianal or rectal lesions, and anal stenosis.
• (8) perineal skin ulceration, infection, and abnormal skin sensation. (9) patients with serious psychological diseases or uncooperative puncture. (10) allergy to narcotic drugs and fear of acupuncture operators. (11) Participants who participated in other clinical trials within 3 months before enrollment.
• (12) other conditions considered by the investigator to be inappropriate to participate in the trial.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhan Xiangyang

  Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhan Xiangyang

CONTACT

021-13253619759; zxy960110@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in Charge

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 16, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12