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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Device: TEAS group; Device: sham group

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 Type: Interventional
• Enrollment (Estimated): 524
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunling Jiang, PhD; Phone Number: 18980601096; Email: jiang_chunling@yahoo.com

Study Locations

• China
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital
    • Contact: Chunling Jiang, PhD; Phone Number: 18980601096; Email: jiang_chunling@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Age 18-80 years old; ASA physical status classⅠ-Ⅲ; 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAS group; 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.	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.
Placebo Comparator: Sham group; Patients in the sham group will receive electrodeattachment but without stimulation.	Device: sham group; Patients in the sham group will receive electrode attachment but without stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Chunling Jiang, PhD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2024HX1564-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No