Liver CancerNCT06406244
Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy
A study testing TEAS group in people with Liver Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cancer
- What is being tested?
- TEAS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 20 Oct 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
Who cannot join
- Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, 610041
Chunling Jiang, PhD, 18980601096, jiang_chunling@yahoo.com
About this study
Official title: Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy.
Read the detailed description
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain and survival in patients undergoing hepatectomy. Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive TEAS 30 min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Patients in the sham group will receive electrode attachment but without stimulation. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival, overall survival at 3 months and 6 months postoperatively.
- Conditions
- Liver Cancer
- Being tested
- TEAS group, sham group
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAS groupDevice
Transcutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30 min before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.
sham groupDevice
Patients in the sham group will receive electrode attachment but without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive 30 min TEAS before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Receives: Device: TEAS group |
| Sham group | Placebo comparator | Patients in the sham group will receive electrodeattachment but without stimulation. Receives: Device: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic pain at 3 months postoperatively
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain, 0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.
Measured: 3 months postoperatively
Secondary outcomes (9)
The incidence of chronic pain at 6 months
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating. Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain, 0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.
Measured: 6 months postoperatively
Overall survival postoperatively
Overall survival is defined as the time between the date from surgery to the date of death.
Measured: Up to 6 months postoperatively
Recurrence-free survival postoperatively
Postoperative re-examination is based on the diagnosis of enhanced CT, MRI, ultrasound or blood examination todetermine whether the patient has recurrence and metastasis. Recurrence-free time refers to the time from surgery to tumor recurrence based on the above CT, MRI, etc.
Measured: Up to 6 months postoperatively
Disability-free survival postoperatively
Patient self-assessment is carried out by using the World Health Organization(WHO) Disability Scale, with a minimum score of 12 points and a maximum score of 60 points. The lower the score, the higher the quality of life.
Measured: Up to 6 months postoperatively
Quality of Recovery Scale Score postoperatively
The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort(5 items), emotional state(4 items), psychological support(2 items), physical independence(2 items), and pain(2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent(QoR-15 > 135), good(122 ≤ QoR-15 ≤ 135), moderate(90 ≤ QoR-15 ≤ 121) and poor(QoR-15 <90).
Measured: Up to 6 months postoperatively
The sleep quality score postoperatively
Postoperative sleep quality is evaluated using the Athens Insomnia Scale(AIS). The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates adiagnosis of insomnia.
Measured: Up to 6 months postoperatively
The anxiety and depression scores postoperatively
Anxiety and depression score will be evaluated using the Hospital Anxiety and Depression Scale(HADS).The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety(HADS-A) and depression(HADS-D).
Measured: Up to 6 months postoperatively
The prevalence of neuropathic pain
The ID Pain scale is used as a validated assessment of neuropathic pain. ID pain questionnaire consists of six items. Pain higher scores suggest a neuropathic component to the pain.
Measured: Up to 6 months postoperatively
Brief Pain Inventory(BPI) pain interference subscale score
BPI pain interference subscale is a 7-item questionnaire asking participants to describe how pain has interfered general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life. Each question is answered on a scale 0(does not interfere) to 10(completely interferes). The total range of score is 0-70. The higher the scores suggest the worse the interference.
Measured: Up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 Apr 2024
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Model description
- Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS group) or the sham groups using a computer-generated random number table.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406244
- Sponsor's protocol ID
- 2024HX1564-2
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06406244
- Acronym / sponsor ID
- 2024HX1564-2
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 9 May 2024 (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 study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy.
Detailed description
This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain and survival in patients undergoing hepatectomy. Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive TEAS 30 min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Patients in the sham group will receive electrode attachment but without stimulation. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival, overall survival at 3 months and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS group) or the sham groups using a computer-generated random number table.
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: TEAS groupPatients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive 30 min TEAS before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. |
| Sham group | Placebo comparator | Device: sham groupPatients in the sham group will receive electrodeattachment but without stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.
Key exclusion criteria (1 listed)
- Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs.
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 |
|---|---|---|
| TEAS groupTranscutaneous electrical acupoint stimulation (TEAS) is a contemporary modification of traditional acupuncture that sends electrical impulses into acupoints through electrodes on the skin surface. In the TEAS group, patients will receive TEAS 30 min before anesthesia until be discharged from the post-anaesthesia care unit (PACU). The same treatment will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. | Device | TEAS group |
| sham groupPatients in the sham group will receive electrode attachment but without stimulation. | Device | Sham group |
Primary outcome
The incidence of chronic pain at 3 months postoperatively
Time frame: 3 months postoperatively
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain, 0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience.
9 secondary outcomes
The incidence of chronic pain at 6 months
Time frame: 6 months postoperatively
Overall survival postoperatively
Time frame: Up to 6 months postoperatively
Recurrence-free survival postoperatively
Time frame: Up to 6 months postoperatively
Disability-free survival postoperatively
Time frame: Up to 6 months postoperatively
Quality of Recovery Scale Score postoperatively
Time frame: Up to 6 months postoperatively
The sleep quality score postoperatively
Time frame: Up to 6 months postoperatively
The anxiety and depression scores postoperatively
Time frame: Up to 6 months postoperatively
The prevalence of neuropathic pain
Time frame: Up to 6 months postoperatively
Brief Pain Inventory(BPI) pain interference subscale score
Time frame: Up to 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Chunling Jiang, PhD study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS group in people with Liver Cancer, run by West China Hospital at 1 site 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 1 inclusion and 1 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunling Jiang, PhD (18980601096, jiang_chunling@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chronic pain at 3 months postoperatively (time frame: 3 months postoperatively). 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 May 2024.