Acupuncture TherapyNCT04887090
Clinical Evaluation of ADCT to Accelerate Perioperative Rehabilitation of Pneumonectomy
A study testing Acupuncture and Drug Compound Technology and Routine perioperative management in people with Acupuncture Therapy and Pneumonectomy, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial summary
This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture Therapy, Pneumonectomy, Perioperative Period
- What is being tested?
- Acupuncture and Drug Compound Technology and Routine perioperative management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with pulmonary nodules requiring thoracoscopic surgery.
- Understand and agree to participate in this study and sign the informed consent.
Who cannot join
- Patients who had previously received TEAS.
- Patients with local skin infection of acupoints.
- Patients with nerve damage in the upper or lower extremities.
- Participants who had participated in or were participating in other clinical trials within 1 month prior to enrollment.
About this study
Official title: Study on Standardization and Clinical Evaluation of Acupuncture and Drug Compound Technology to Accelerate Perioperative Rehabilitation of Pneumonectomy
This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs.
With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients.
In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.
Read the detailed description
Since the first successful pulmonary resection under acupuncture anesthesia in 1960，the clinical application and research of lung surgery under acupuncture anesthesia has gone through 60 years，serving countless patients and achieving rich results． Looking back on its development，the application of acupuncture anesthesia in lung surgery has evolved from simple acupuncture anesthesia without intubation in the 1960s to combined anesthesia of acupuncture and narcotic drugs under tracheal intubation in the early 1980s．In recent years，with the popularization of endoscopic technology，the investigators had extensively carried out thoracoscopic lung surgery under combined anesthesia of acupuncture and narcotic drugs without intubation．Clinical practice and research have indicated that the thoracoscopic lung surgery under combined anesthesia without intubation shows obvious advantages，and the selection of intraoperative anesthesia methods，acupoints and stimulation methods are becoming mature．At present，the investigators are working on expanded application of acupuncture in perioperative period of lung surgery，which shows a promising future．In the future，it is necessary to improve the theory of acupuncture anesthesia，unify the clinical operation standards，establish an objective evaluation system，and explore the mechanism of acupuncture anesthesia． This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs.
With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients.
In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.
- Conditions
- Acupuncture Therapy, Pneumonectomy, Perioperative Period, Analgesia
- Being tested
- Acupuncture and Drug Compound Technology, Routine perioperative management
- Keywords
- Acupuncture Therapy, Pneumonectomy, Perioperative Recovery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and Drug Compound TechnologyDevice
Also called Transcutaneous electrical acupoints stimulation treatment
Before operation: The points of the meridian: Hegu, Neiguan, Chize, Zusanli, both sides are taken. TEAS (transcutaneous electrical acupoints stimulation) was performed every day for three days before the operation, using the Han's acupoint nerve stimulator to adjust the density and density waveforms at a frequency of 2/100 Hz (Hz). Current intensity is 10mA, and all acupuncture points are continuously stimulated for 30 minutes. During the operation: take the acupoints Hegu, Neiguan, Houxi, and Zhigou on both sides and give TEAS 30 minutes before induction of anesthesia. The stimulation intensity and frequency are the same as those before the operation until the end of the operation. Postoperative: Take the acupoints Chize, Waiguan, Taichong, and Yanglingquan, and take both sides. TEAS will be performed every 12 hours from the first day after surgery. Each treatment is 30 minutes until 48 hours after surgery. The intensity and frequency are the same as before surgery.
Routine perioperative managementOther
Comprehensive evaluation of cardiopulmonary function, preparation of respiratory tract, active treatment of coexisting diseases before operation, correction of water and electrolyte disorders and hypoproteinemia before operation. To prevent cross-infection during the operation, the intraoperative blood volume should be supplemented within the tolerance of cardiac function, the tissue perfusion should be sufficient, and the infusion should be uniform. Strengthen respiratory care after operation, prevent cardiovascular complications, pay attention to the speed and amount of blood transfusion, encourage early activities, promote lung expansion and prevent thrombophlebitis.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and drug compound technology group | Experimental | Routine perioperative management and transcutaneous electrical acupoints stimulation treatment Receives: Device: Acupuncture and Drug Compound Technology; Other: Routine perioperative management |
| Control group | Other | Routine perioperative management Receives: Other: Routine perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chest tube removal time (h)
The time from the end of surgery to the removal of the thoracic catheter will be recorded
Measured: up to 2 weeks after surgery
Secondary outcomes (9)
First exhaust time after operation (h)
The time between the patient's first exhaust and the end of surgery will be recorded.
Measured: up to 1 week after surgery
First defecation time after operation (h)
The time between the patient's first defecation and the end of surgery will be recorded.
Measured: up to 1 week after surgery
Visual Analog Scale of Pain
Visual analogue scale of pain will be used to evaluate the pain level of the surgical incision, and the score will be recorded.The 10cm sliding scale has 10 scales on one side, and the two ends are respectively "0" and "10" points. A point of 0 means no pain, and a point of 10 means the most severe pain that is unbearable.
Measured: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Duration of postoperative hospital stay (d)
Days between the day of discharge and surgery will be recorded.
Measured: up to 2 weeks after surgery
C-reactive protein (CRP,mg/L)
Inflammatory biomarker CRP will be determined by immunotransmission turbidimetry.
Measured: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Noradrenaline (NE,µg/L)
Stress response biomarker NE will be determined by immunotransmission turbidimetry.
Measured: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Postoperative stay time in the intensive care unit (h)
Record the time between the day of patient transfer from the ICU and the end of surgery.
Measured: up to 1 week after surgery
Postoperative antibiotics use days (d)
Duration of postoperative antibiotics use will be recorded
Measured: up to 1 week after surgery
Inpatient medical expenses
Record expenses incurred during the patient's hospitalization
Measured: up to 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study startJul 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acupuncture TherapyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulun Li, Shanghai Yueyang Integrated Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887090
- Sponsor's protocol ID
- 20210421
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Wu X, Ju C, Kurexi S, Zhou X, Wang K, Chen T. Efficacy and safety of transcutaneous electrical acupoint stimulation for preoperative anxiety in thoracoscopic surgery: a randomized controlled trial. Front Med (Lausanne). 2025 Apr 7;12:1527993. doi: 10.3389/fmed.2025.1527993. eCollection 2025.
PubMed 40259979
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Standardization and Clinical Evaluation of Acupuncture and Drug Compound Technology to Accelerate Perioperative Rehabilitation of Pneumonectomy
- ClinicalTrials.gov ID
- NCT04887090
- Acronym / sponsor ID
- 20210421
- Conditions
- Acupuncture Therapy, Pneumonectomy, Perioperative Period, Analgesia
- Keywords
- Acupuncture Therapy, Pneumonectomy, Perioperative Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 May 2021 (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.
This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs.
With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients.
In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.
Detailed description
Since the first successful pulmonary resection under acupuncture anesthesia in 1960，the clinical application and research of lung surgery under acupuncture anesthesia has gone through 60 years，serving countless patients and achieving rich results． Looking back on its development，the application of acupuncture anesthesia in lung surgery has evolved from simple acupuncture anesthesia without intubation in the 1960s to combined anesthesia of acupuncture and narcotic drugs under tracheal intubation in the early 1980s．In recent years，with the popularization of endoscopic technology，the investigators had extensively carried out thoracoscopic lung surgery under combined anesthesia of acupuncture and narcotic drugs without intubation．Clinical practice and research have indicated that the thoracoscopic lung surgery under combined anesthesia without intubation shows obvious advantages，and the selection of intraoperative anesthesia methods，acupoints and stimulation methods are becoming mature．At present，the investigators are working on expanded application of acupuncture in perioperative period of lung surgery，which shows a promising future．In the future，it is necessary to improve the theory of acupuncture anesthesia，unify the clinical operation standards，establish an objective evaluation system，and explore the mechanism of acupuncture anesthesia． This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs.
With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients.
In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and drug compound technology group | Experimental | Device: Acupuncture and Drug Compound Technology, Other: Routine perioperative managementRoutine perioperative management and transcutaneous electrical acupoints stimulation treatment |
| Control group | Other | Other: Routine perioperative managementRoutine perioperative management |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with pulmonary nodules requiring thoracoscopic surgery.
- Understand and agree to participate in this study and sign the informed consent.
Key exclusion criteria (4 listed)
- Patients who had previously received TEAS.
- Patients with local skin infection of acupoints.
- Patients with nerve damage in the upper or lower extremities.
- Participants who had participated in or were participating in other clinical trials within 1 month prior to enrollment.
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 |
|---|---|---|
| Acupuncture and Drug Compound TechnologyAlso: Transcutaneous electrical acupoints stimulation treatmentBefore operation: The points of the meridian: Hegu, Neiguan, Chize, Zusanli, both sides are taken. TEAS (transcutaneous electrical acupoints stimulation) was performed every day for three days before the operation, using the Han's acupoint nerve stimulator to adjust the density and density waveforms at a frequency of 2/100 Hz (Hz). Current intensity is 10mA, and all acupuncture points are continuously stimulated for 30 minutes. During the operation: take the acupoints Hegu, Neiguan, Houxi, and Zhigou on both sides and give TEAS 30 minutes before induction of anesthesia. The stimulation intensity and frequency are the same as those before the operation until the end of the operation. Postoperative: Take the acupoints Chize, Waiguan, Taichong, and Yanglingquan, and take both sides. TEAS will be performed every 12 hours from the first day after surgery. Each treatment is 30 minutes until 48 hours after surgery. The intensity and frequency are the same as before surgery. | Device | Acupuncture and drug compound technology group |
| Routine perioperative managementComprehensive evaluation of cardiopulmonary function, preparation of respiratory tract, active treatment of coexisting diseases before operation, correction of water and electrolyte disorders and hypoproteinemia before operation. To prevent cross-infection during the operation, the intraoperative blood volume should be supplemented within the tolerance of cardiac function, the tissue perfusion should be sufficient, and the infusion should be uniform. Strengthen respiratory care after operation, prevent cardiovascular complications, pay attention to the speed and amount of blood transfusion, encourage early activities, promote lung expansion and prevent thrombophlebitis. | Other | Acupuncture and drug compound technology group, Control group |
Primary outcome
Postoperative chest tube removal time (h)
Time frame: up to 2 weeks after surgery
The time from the end of surgery to the removal of the thoracic catheter will be recorded
9 secondary outcomes
First exhaust time after operation (h)
Time frame: up to 1 week after surgery
First defecation time after operation (h)
Time frame: up to 1 week after surgery
Visual Analog Scale of Pain
Time frame: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Duration of postoperative hospital stay (d)
Time frame: up to 2 weeks after surgery
C-reactive protein (CRP,mg/L)
Time frame: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Noradrenaline (NE,µg/L)
Time frame: The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.
Postoperative stay time in the intensive care unit (h)
Time frame: up to 1 week after surgery
Postoperative antibiotics use days (d)
Time frame: up to 1 week after surgery
Inpatient medical expenses
Time frame: up to 2 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 40259979Zhang J, Wu X, Ju C, Kurexi S, Zhou X, Wang K, Chen T. Efficacy and safety of transcutaneous electrical acupoint stimulation for preoperative anxiety in thoracoscopic surgery: a randomized controlled trial. Front Med (Lausanne). 2025 Apr 7;12:1527993. doi: 10.3389/fmed.2025.1527993. eCollection 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Drug Compound Technology and Routine perioperative management in people with Acupuncture Therapy and Pneumonectomy, run by Shanghai Yueyang Integrated Medicine Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative chest tube removal time (h) (time frame: up to 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887090, which also lists 1 linked publication.
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 8 Jul 2021.