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Efficacy of 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

Efficacy of 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000567
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Electroacupuncture group:Electroacupuncture plus local anesthesia was applied
Sham-electroacupuncture group:Sham electroacupuncture plus local anesthesia was applied

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

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) consistent with the indication of prostate biopsy: suspicious prostate nodules detected by digital rectal examination any PSA value; Or transrectal ultrasound or magnetic resonance imaging found suspicious lesions any PSA value; Or PSA>10ng/ml any f/T PSA (ratio of free PSA to total PSA) and PSAD values; Or abnormal f/T PSA value and/or PSAD value. Patients underwent prostate biopsy for the first time.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
NRS max;

Secondary

MeasureTime frame
Blood pressure and heart rate fluctuations;Prostate Cancer Detection Rate;Salivary cortisol;Acupuncture related adverse events;VAS-a;Satisfaction with sleep;NRS AUC1h-24h;Assessment of external manifestations of pain;Incidence of rescue analgesia and total number of rescue analgesia;Anesthesia satisfaction;

Countries

China

Contacts

Public ContactDongliang Xu

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Dr_xudongliang@shutcm.edu.cn13918829767

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026