Joint ReplacementTEASNCT02979028
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty
A study testing TEAS in people with Joint Replacement, run by Second Hospital of Shanxi Medical University.
Trial summary
This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement… Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Joint Replacement
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to Apr 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASAⅡ-Ⅲ,elective operation patients
- No other severe complications history
- Able to give informed consent
Who cannot join
- Having severe comorbidity resulting in estimated life expectancy <1 year.
- Infection at the electroacupuncture site.
- Suffered from neurologic disorder or impaired mental state
- Participate in the other clinical trial 3 months before the enrollment
- No suitable to participate in this experiment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial
This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.
Read the detailed description
The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.
- Conditions
- Joint Replacement
- Being tested
- TEAS
- Keywords
- TEAS, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
Transcutaneous electrical acupoint stimulation
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | Electric stimulation was given through electrode attached to acupoints SP6 and ST36 .TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. Receives: Device: TEAS |
| Sham group | Sham comparator | Non-acupoint is located 2cm inward to the specific acupoints.TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. Receives: Device: TEAS |
| Control group | Placebo comparator | Control patients will receive the same treatment without electrical stimulation. Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative complications
Participants will be followed for the incidence of postoperative complications
Measured: within 30 days after operation
Secondary outcomes (3)
length of postoperative hospital stay
Participants will be followed for the duration of hospital stay
Measured: an expected average of 1 week
Quality of life during 30 days after surgery
evaluate the quality of life after surgery by WHO QOL-BREF scale with interview ，WHO QOL-BREF scale includes five aspects: physical, psychological, social, environmental, integrated, divided into five levels
Measured: One month
ICU transfer rate after operation
Participants will be followed for ICU transfer rate after operation
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start1 May 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Joint ReplacementStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Zheng Guo, Study chair, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979028
- Sponsor's protocol ID
- zxy
- Acronym
- TEAS
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huddleston JI, Maloney WJ, Wang Y, Verzier N, Hunt DR, Herndon JH. Adverse events after total knee arthroplasty: a national Medicare study. J Arthroplasty. 2009 Sep;24(6 Suppl):95-100. doi: 10.1016/j.arth.2009.05.001. Epub 2009 Jul 4.
PubMed 19577884Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.
PubMed 15383478Singh JA, Jensen MR, Harmsen WS, Gabriel SE, Lewallen DG. Cardiac and thromboembolic complications and mortality in patients undergoing total hip and total knee arthroplasty. Ann Rheum Dis. 2011 Dec;70(12):2082-8. doi: 10.1136/ard.2010.148726. Epub 2011 Oct 21.
PubMed 22021865Krecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implants - a prospective study. Int J Occup Med Environ Health. 2012 Sep;25(4):463-9. doi: 10.2478/S13382-012-0029-3. Epub 2012 Dec 3.
PubMed 23212287Hou L, Chen C, Xu L, Yin P, Peng W. Electrical stimulation of acupoint combinations against deep venous thrombosis in elderly bedridden patients after major surgery. J Tradit Chin Med. 2013 Apr;33(2):187-93. doi: 10.1016/s0254-6272(13)60123-5.
PubMed 23789215Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.
PubMed 20172127Ni X, Xie Y, Wang Q, Zhong H, Chen M, Wang F, Xiong L. Cardioprotective effect of transcutaneous electric acupoint stimulation in the pediatric cardiac patients: a randomized controlled clinical trial. Paediatr Anaesth. 2012 Aug;22(8):805-11. doi: 10.1111/j.1460-9592.2012.03822.x. Epub 2012 Mar 2.
PubMed 22380768
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02979028
- Acronym / sponsor ID
- TEAS / zxy
- Conditions
- Joint Replacement
- Keywords
- TEAS, complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 1 Dec 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.
This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.
Detailed description
The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: TEASElectric stimulation was given through electrode attached to acupoints SP6 and ST36 .TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. |
| Sham group | Sham comparator | Device: TEASNon-acupoint is located 2cm inward to the specific acupoints.TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery. |
| Control group | Placebo comparator | Device: TEASControl patients will receive the same treatment without electrical stimulation. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASAⅡ-Ⅲ,elective operation patients
- No other severe complications history
- Able to give informed consent
Key exclusion criteria (5 listed)
- Having severe comorbidity resulting in estimated life expectancy <1 year.
- Infection at the electroacupuncture site.
- Suffered from neurologic disorder or impaired mental state
- Participate in the other clinical trial 3 months before the enrollment
- No suitable to participate in this experiment
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 |
|---|---|---|
| TEASTranscutaneous electrical acupoint stimulation | Device | Control group, Sham group, TEAS group |
Primary outcome
The incidence of postoperative complications
Time frame: within 30 days after operation
Participants will be followed for the incidence of postoperative complications
3 secondary outcomes
length of postoperative hospital stay
Time frame: an expected average of 1 week
Quality of life during 30 days after surgery
Time frame: One month
ICU transfer rate after operation
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Background: PubMed 19577884Huddleston JI, Maloney WJ, Wang Y, Verzier N, Hunt DR, Herndon JH. Adverse events after total knee arthroplasty: a national Medicare study. J Arthroplasty. 2009 Sep;24(6 Suppl):95-100. doi: 10.1016/j.arth.2009.05.001. Epub 2009 Jul 4.
- Background: PubMed 15383478Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.
- Background: PubMed 22021865Singh JA, Jensen MR, Harmsen WS, Gabriel SE, Lewallen DG. Cardiac and thromboembolic complications and mortality in patients undergoing total hip and total knee arthroplasty. Ann Rheum Dis. 2011 Dec;70(12):2082-8. doi: 10.1136/ard.2010.148726. Epub 2011 Oct 21.
- Background: PubMed 23212287Krecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implants - a prospective study. Int J Occup Med Environ Health. 2012 Sep;25(4):463-9. doi: 10.2478/S13382-012-0029-3. Epub 2012 Dec 3.
- Background: PubMed 23789215Hou L, Chen C, Xu L, Yin P, Peng W. Electrical stimulation of acupoint combinations against deep venous thrombosis in elderly bedridden patients after major surgery. J Tradit Chin Med. 2013 Apr;33(2):187-93. doi: 10.1016/s0254-6272(13)60123-5.
- Background: PubMed 20172127Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.
- Background: PubMed 22380768Ni X, Xie Y, Wang Q, Zhong H, Chen M, Wang F, Xiong L. Cardioprotective effect of transcutaneous electric acupoint stimulation in the pediatric cardiac patients: a randomized controlled clinical trial. Paediatr Anaesth. 2012 Aug;22(8):805-11. doi: 10.1111/j.1460-9592.2012.03822.x. Epub 2012 Mar 2.
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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.
Zheng Guo study chair
Second Hospital of Shanxi Medical University
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Joint Replacement, run by Second Hospital of Shanxi Medical University.
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 3 inclusion and 5 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 18 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-ying Zhao (13513616985, zhaoxy06@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative complications (time frame: within 30 days after operation). 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 NCT02979028, which also lists 7 linked publications.
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 18 Apr 2017.