PainASDASNCT02741726
Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy
A study testing acupoint stimulation and no stimulation in people with Pain, run by Zhihong LU at 6 sites in China.
Trial summary
The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- acupoint stimulation and no stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- 6 sitesChina
- Study dates
- 25 May 2016to 23 Oct 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for operation of breast cancer；
- ASA（American Society of Anesthesiologists）I-II；
- Aged between 18 and 65；
- Informed consented。
Who cannot join
- Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
- Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
- Certain/suspicious addiction with alcohol, analgesics or other drugs；
- Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
- Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
- Suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot;
- Severe dysfunction of liver or kidney meaning one of ALT（Alanine Transaminase）, AST（Aspartate Transaminase）, ALP（alkaline phosphatase） or TBIL（total bilirubin） is 2 times higher that normal or creatinine clearance < 30 ml/min or serum creatinine > 177umol/L;
- Participate in the other clinical trial 3 month before the enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
First Afiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710005
First Afiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710022
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
People's hospital of Zhengzhou University
Zhengzhou, Henan, 450003
First Afiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.
Read the detailed description
Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current. The frequency of TEAS is set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded. Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. The adverse events were recorded.
- Conditions
- Pain
- Being tested
- acupoint stimulation, no stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint stimulationDevice
Also called transcutaneous electrical acupoint stimulation
Electric stimulation was given through electrode attached to acupoints
no stimulationDevice
patients were only attached electrodes without electric current
| Study group | Role | What they receive |
|---|---|---|
| dual acupoint stimulation | Experimental | The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), electric stimulation was given through electrode attached to the acupoints. Receives: Device: acupoint stimulation |
| single acupoint stimulation | Experimental | The acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints. Receives: Device: acupoint stimulation |
| no stimulation | Placebo comparator | false stimulation group only attach electrodes without electric current. Receives: Device: no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic pain six months after surgery
Measured: six months after surgery
Secondary outcomes (11)
Incidence of chronic pain three months after surgery
Measured: three months after surgery
Remifentanil consumption during the surgery
Measured: from start of surgery to end of surgery, at an average of 2.5 hours
the time to the first verbal response
Measured: end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
the time to extubation
Measured: end of the anesthetics infusion to extubation,on an average of 30 minutes
postoperative nausea and vomiting within 24 h after surgery
Measured: end of surgery to 24 hours after surgery,on an average of 24 hours
respiratory depression within 24 hours after surgery
Measured: end of surgery to 24 hours after surgery,on an average of 24 hours
patients' s satisfaction scores on analgesia within 24 hours after surgery
Measured: end of surgery to 24 hours after surgery,on an average of 24 hours
Visual Analogue Scale scores within 24 hours after surgery
Measured: end of surgery to 24 hours after surgery,on an average of 24 hours
demand of rescue analgesics within 24 hours after surgery
Measured: end of surgery to 24 hours after surgery,on an average of 24 hours
pain score at 3m after surgery
Measured: three months after surgery
pain score at 6m after surgery
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start25 May 2016
- Primary completion23 Oct 2017
- Study completion23 Oct 2018
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 PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Hailong Dong, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741726
- Sponsor's protocol ID
- XJH-A-2016-04-12
- Acronym
- ASDAS
- Status last verified
- Oct 2019
- First submitted
- 13 Apr 2016
- Last updated
- 16 Oct 2019
- Results posted
- No
- Individual data sharing
- Yes: IPD including those about primary endpoint and secondary endpoints would be available to other researchers.
Publications
Lu Z, Wang Q, Sun X, Zhang W, Min S, Zhang J, Zhao W, Jiang J, Wang Y, Zhu Y, Zheng L, Wang Y, Guo Y, Zhang L, Wang L, Lei C, Liu T, Yang X, Zhang J, Li C, Zhang N, Dong H, Xiong L. Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial. J Clin Anesth. 2021 Nov;74:110453. doi: 10.1016/j.jclinane.2021.110453. Epub 2021 Jul 13.
PubMed 34271271
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined-acupoint or Single-acupoint Stimulation Before Surgery on Post Mastectomy Pain: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02741726
- Acronym / sponsor ID
- ASDAS / XJH-A-2016-04-12
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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.
The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.
Detailed description
Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current. The frequency of TEAS is set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded. Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. The adverse events were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dual acupoint stimulation | Experimental | Device: acupoint stimulationThe acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), electric stimulation was given through electrode attached to the acupoints. |
| single acupoint stimulation | Experimental | Device: acupoint stimulationThe acupoints of single point group is bilateral Neiguan points(PC6), Electric stimulation was given through electrode attached to the acupoints. |
| no stimulation | Placebo comparator | Device: no stimulationfalse stimulation group only attach electrodes without electric current. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for operation of breast cancer；
- ASA（American Society of Anesthesiologists）I-II；
- Aged between 18 and 65；
- Informed consented。
Key exclusion criteria (8 listed)
- Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
- Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
- Certain/suspicious addiction with alcohol, analgesics or other drugs；
- Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
- Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
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 |
|---|---|---|
| acupoint stimulationAlso: transcutaneous electrical acupoint stimulationElectric stimulation was given through electrode attached to acupoints | Device | dual acupoint stimulation, single acupoint stimulation |
| no stimulationpatients were only attached electrodes without electric current | Device | no stimulation |
Primary outcome
Incidence of chronic pain six months after surgery
Time frame: six months after surgery
11 secondary outcomes
Incidence of chronic pain three months after surgery
Time frame: three months after surgery
Remifentanil consumption during the surgery
Time frame: from start of surgery to end of surgery, at an average of 2.5 hours
the time to the first verbal response
Time frame: end of the anesthetics infusion to patient's first response to verbal command,on an average of 30 minutes
the time to extubation
Time frame: end of the anesthetics infusion to extubation,on an average of 30 minutes
postoperative nausea and vomiting within 24 h after surgery
Time frame: end of surgery to 24 hours after surgery,on an average of 24 hours
respiratory depression within 24 hours after surgery
Time frame: end of surgery to 24 hours after surgery,on an average of 24 hours
patients' s satisfaction scores on analgesia within 24 hours after surgery
Time frame: end of surgery to 24 hours after surgery,on an average of 24 hours
Visual Analogue Scale scores within 24 hours after surgery
Time frame: end of surgery to 24 hours after surgery,on an average of 24 hours
demand of rescue analgesics within 24 hours after surgery
Time frame: end of surgery to 24 hours after surgery,on an average of 24 hours
pain score at 3m after surgery
Time frame: three months after surgery
pain score at 6m after surgery
Time frame: six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Derived from this study: PubMed 34271271Lu Z, Wang Q, Sun X, Zhang W, Min S, Zhang J, Zhao W, Jiang J, Wang Y, Zhu Y, Zheng L, Wang Y, Guo Y, Zhang L, Wang L, Lei C, Liu T, Yang X, Zhang J, Li C, Zhang N, Dong H, Xiong L. Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial. J Clin Anesth. 2021 Nov;74:110453. doi: 10.1016/j.jclinane.2021.110453. Epub 2021 Jul 13.
- Individual participant dataSharing planned: Yes. IPD including those about primary endpoint and secondary endpoints would be available to other researchers.
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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.
Hailong Dong study chair
Air Force Military Medical University, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint stimulation and no stimulation in people with Pain, run by Zhihong LU at 6 sites in China.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of chronic pain six months after surgery (time frame: six months 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 NCT02741726, 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 16 Oct 2019.