Prostate CancerEATPULANCT07069049
Electroacupuncture in the Treatment of Patients Undergoing Transperineal Prostate Biopsy Under Local Anesthesia
A study testing electroacupuncture in people with Prostate Cancer, run by Shanghai University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2025to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) To voluntarily participate in the study, I or his legal representative signed a written informed consent.
- 18-80 years old (including 18 and 80 years old), male. (3) in accordance with the indication of prostate biopsy.
Who cannot join
- (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.
- 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).
- in the decompensated stage of cardiac insufficiency; A disease with a tendency to bleed heavily.
- severe immunosuppression. (6) hypertension, diabetes and other complications were poorly controlled or unstable.
- complicated with severe internal or external hemorrhoids, perianal or rectal lesions, and anal stenosis.
- 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.
- other conditions considered by the investigator to be inappropriate to participate in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
Prostate cancer ranks the first in the incidence of male malignant tumors and the second in mortality in the world, which seriously affects men's physical and mental health. At present, the gold standard for the diagnosis of prostate cancer is prostate biopsy. Transrectal biopsy and transperineal biopsy are commonly used. There is no significant difference in the detection rate of prostate cancer between the two methods, but each has its advantages and disadvantages. Transrectal prostate biopsy can be performed with local anesthesia, but the risk of postoperative infection is high. After transrectal prostate biopsy, bacteriuria was detected in 44% of patients and bacteremia in 16%, with infection as the leading cause of rehospitalization within 2 weeks after discharge (81%). Transperineal prostate biopsy does not require bowel preparation, and the risk of infection is minimal. However, this approach is prone to significant pain, and most cases are completed by general anesthesia. However, the operation time of general anesthesia is long, the economic cost is high, and the majority of prostate biopsy patients are elderly patients, with more underlying heart and lung diseases, and the risk of anesthesia is high. The convenience of local anesthesia and out-patient biopsy will be the development trend of prostate biopsy in the future. However, pain and anxiety caused by local anesthesia are not negligible factors during prostate biopsy. Studies have shown that approximately 50% of patients experience moderate or greater pain during prostate biopsy under local anesthesia. The use of analgesic drugs such as lidocaine gel and non-steroidal anti-inflammatory drugs (such as diclofenac) can not significantly reduce the pain caused by probe manipulation and biopsy sampling. In the process of local anesthesia surgery, due to the interaction between anxiety and pain for surgery, patients will also have vagal symptoms such as decreased blood pressure and bradycardia, which will increase the risk of surgery. In clinical practice, some patients give up pathological biopsy due to the fear of puncture, thus missing the best period of diagnosis and treatment. Therefore, reducing the anxiety and pain caused by prostate biopsy is the key link to complete prostate biopsy under local anesthesia.
Acupuncture and moxibustion is an important part of traditional Chinese medicine, which can be divided into hand acupuncture and electroacupuncture. Electroacupuncture is a way of stimulating acupoints by connecting appropriate current after hand acupuncture to get qi, which can enhance the sensation of acupuncture and play a continuous stimulating effect on acupoints, thus enhancing the therapeutic effect of acupuncture and moxibustion. Electroacupuncture has clinically significant effects on many types of pain management. Studies have shown that electroacupuncture has a significant effect on perioperative analgesia and can improve patients' satisfaction with surgery. In addition, electroacupuncture can also relieve perioperative anxiety, reduce stress response, and maintain the stability of cardiopulmonary function during the operation. Our previous observational study has shown that electroacupuncture can reduce the pain score and anxiety score of patients undergoing perineal prostate biopsy under local anesthesia, improve the surgical cooperation, without postoperative complications and high patient satisfaction. At present, electroacupuncture is not recommended as a analgesic and anti-anxiety regimen in prostate biopsy guidelines. In order to further verify the analgesic and anti-anxiety effect of electroacupuncture in prostate biopsy under local anesthesia, improve the level of clinical evidence, and provide a basis for clinical promotion in the future, it is necessary to conduct high-quality randomized controlled and multi-center clinical trials.
This study was a randomized, single-blind, placebo-controlled, multi-center clinical trial. After the subjects met the inclusion and exclusion criteria were included, they were randomly assigned to the electroacupuncture group and the sham electroacupuncture group according to the ratio of 1:1. The potential mechanism of EA in relieving pain and anxiety was explored.
- Conditions
- Prostate Cancer
- Being tested
- electroacupuncture, Sham-electroacupunture
- Keywords
- electroacupuncture, Prostate Needle biopsy, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
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).
Sham-electroacupuntureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham-electroacupunture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The end of the operation
Secondary outcomes (4)
Area under the curve for cumulative pain scores
Use Numerical Rating Scale to Assess the maximum pain level in 1h-24h after after the completion of surgery
Measured: 1h、6h、24h after completion of surgery
Visual Analogue Scale for anxiety
Visual Analogue Scale for anxiety, 0-10,higher scores mean a worse outcome.
Measured: At the beginning of operation and at the completion of operation
Incidence of rescue analgesia and total number of rescue analgesia
Incidence and number
Measured: At the completion of operation
Blood pressure
Blood pressure
Measured: At the completion of the operation and 20 min before the start of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start28 Dec 2025 (estimated)
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyang Zhan, Shanghai University of Traditional Chinese Medicine
- Investigators
- Zhan Xiangyang, Principal investigator, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069049
- Sponsor's protocol ID
- 2024-1592-175-01
- Acronym
- EATPULA
- Status last verified
- Dec 2025
- First submitted
- 20 May 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07069049
- Acronym / sponsor ID
- EATPULA / 2024-1592-175-01
- Conditions
- Prostate Cancer
- Keywords
- electroacupuncture, Prostate Needle biopsy, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 28 Dec 2025 (estimated)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate cancer ranks the first in the incidence of male malignant tumors and the second in mortality in the world, which seriously affects men's physical and mental health. At present, the gold standard for the diagnosis of prostate cancer is prostate biopsy. Transrectal biopsy and transperineal biopsy are commonly used. There is no significant difference in the detection rate of prostate cancer between the two methods, but each has its advantages and disadvantages. Transrectal prostate biopsy can be performed with local anesthesia, but the risk of postoperative infection is high. After transrectal prostate biopsy, bacteriuria was detected in 44% of patients and bacteremia in 16%, with infection as the leading cause of rehospitalization within 2 weeks after discharge (81%). Transperineal prostate biopsy does not require bowel preparation, and the risk of infection is minimal. However, this approach is prone to significant pain, and most cases are completed by general anesthesia. However, the operation time of general anesthesia is long, the economic cost is high, and the majority of prostate biopsy patients are elderly patients, with more underlying heart and lung diseases, and the risk of anesthesia is high. The convenience of local anesthesia and out-patient biopsy will be the development trend of prostate biopsy in the future. However, pain and anxiety caused by local anesthesia are not negligible factors during prostate biopsy. Studies have shown that approximately 50% of patients experience moderate or greater pain during prostate biopsy under local anesthesia. The use of analgesic drugs such as lidocaine gel and non-steroidal anti-inflammatory drugs (such as diclofenac) can not significantly reduce the pain caused by probe manipulation and biopsy sampling. In the process of local anesthesia surgery, due to the interaction between anxiety and pain for surgery, patients will also have vagal symptoms such as decreased blood pressure and bradycardia, which will increase the risk of surgery. In clinical practice, some patients give up pathological biopsy due to the fear of puncture, thus missing the best period of diagnosis and treatment. Therefore, reducing the anxiety and pain caused by prostate biopsy is the key link to complete prostate biopsy under local anesthesia.
Acupuncture and moxibustion is an important part of traditional Chinese medicine, which can be divided into hand acupuncture and electroacupuncture. Electroacupuncture is a way of stimulating acupoints by connecting appropriate current after hand acupuncture to get qi, which can enhance the sensation of acupuncture and play a continuous stimulating effect on acupoints, thus enhancing the therapeutic effect of acupuncture and moxibustion. Electroacupuncture has clinically significant effects on many types of pain management. Studies have shown that electroacupuncture has a significant effect on perioperative analgesia and can improve patients' satisfaction with surgery. In addition, electroacupuncture can also relieve perioperative anxiety, reduce stress response, and maintain the stability of cardiopulmonary function during the operation. Our previous observational study has shown that electroacupuncture can reduce the pain score and anxiety score of patients undergoing perineal prostate biopsy under local anesthesia, improve the surgical cooperation, without postoperative complications and high patient satisfaction. At present, electroacupuncture is not recommended as a analgesic and anti-anxiety regimen in prostate biopsy guidelines. In order to further verify the analgesic and anti-anxiety effect of electroacupuncture in prostate biopsy under local anesthesia, improve the level of clinical evidence, and provide a basis for clinical promotion in the future, it is necessary to conduct high-quality randomized controlled and multi-center clinical trials.
This study was a randomized, single-blind, placebo-controlled, multi-center clinical trial. After the subjects met the inclusion and exclusion criteria were included, they were randomly assigned to the electroacupuncture group and the sham electroacupuncture group according to the ratio of 1:1. The potential mechanism of EA in relieving pain and anxiety was explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupunture | Experimental | Other: electroacupunctureIn 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. |
| Sham-electroacupunture | Sham comparator | Other: Sham-electroacupuntureThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) To voluntarily participate in the study, I or his legal representative signed a written informed consent.
- 18-80 years old (including 18 and 80 years old), male. (3) in accordance with the indication of prostate biopsy.
Key exclusion criteria (7 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureSterile 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). | Other | electroacupunture |
| Sham-electroacupuntureSham 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. | Other | Sham-electroacupunture |
Primary outcome
The maximum pain level
Time frame: The end of the operation
Use Numerical Rating Scale to Assess the maximum pain level during the operation,0-100mm,higher scores mean a worse outcome.
4 secondary outcomes
Area under the curve for cumulative pain scores
Time frame: 1h、6h、24h after completion of surgery
Visual Analogue Scale for anxiety
Time frame: At the beginning of operation and at the completion of operation
Incidence of rescue analgesia and total number of rescue analgesia
Time frame: At the completion of operation
Blood pressure
Time frame: At the completion of the operation and 20 min before the start of the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhan Xiangyang principal investigator
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Prostate Cancer, run by Shanghai University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhan Xiangyang (021-13253619759, zxy960110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum pain level (time frame: The end of the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.