Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy

Liver Cancer Clinical Trial

Official title:

Efficacy of Transcutaneous Electrical Acupoint Stimulation on Chronic Pain and Survival in Patients Undergoing Hepatectomy: a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406244
• Other study ID #: 2024HX1564-2
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: October 20, 2026

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiang_chunling[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: October 20, 2026
• Est. primary completion date: April 20, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Age 18-80 years old; ASA physical status class?-?; Patients scheduled for elective hepatectomy.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Chronic Pain
• Liver Cancer

Intervention

Device:
• TEAS group
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 group
Patients in the sham group will receive electrode attachment but without stimulation.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months postoperatively
Secondary	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.	6 months postoperatively
Secondary	Overall survival postoperatively	Overall survival is defined as the time between the date from surgery to the date of death.	Up to 6 months postoperatively
Secondary	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.	Up to 6 months postoperatively
Secondary	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.	Up to 6 months postoperatively
Secondary	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).	Up to 6 months postoperatively
Secondary	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.	Up to 6 months postoperatively
Secondary	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).	Up to 6 months postoperatively
Secondary	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.	Up to 6 months postoperatively
Secondary	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.	Up to 6 months postoperatively