Clinical trial · Interventional
Electroacupuncture in the Treatment of Patients Undergoing Transperineal Prostate Biopsy Under Local Anesthesia
Electroacupuncture in the Treatment of Patients Undergoing Transperineal Prostate Biopsy Under Local Anesthesia: a Randomized, Single-blind, Sham-electroacupuncture Parallel Control, Multi-center Clinical Trial
- 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)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| electroacupuncture | Other | — | UNRESOLVED |
| Sham-electroacupunture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- electroacupunture
- description
- 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.
- interventionNames
- Other: electroacupuncture
- type
- SHAM_COMPARATOR
- label
- Sham-electroacupunture
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- (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. Exclusion Criteria: * (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.
References
Publications (0)
Data not yet available