To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy
NCT ID:
NCT06406244
Condition:
Liver Cancer
Conditions: Official terms:
Chronic Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Blinding of participants will be maintained throughout the observation period. The sham
group will receive electrode attachment but without stimulation. Throughout the study,
for adequate blinding, an opaque tape will be applied to the patient's skin above the
electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients
will be informed that they might or might not feel a tingling sensation around the
acupoints when the TEAS device is working. The patients should not be unblinded until the
statistical analysis of the study data is completed.
Intervention:
Intervention type:
Device
Intervention name:
TEAS group
Description:
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.
Arm group label:
TEAS group
Intervention type:
Device
Intervention name:
sham group
Description:
Patients in the sham group will receive electrode attachment but without stimulation.
Arm group label:
Sham group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunling Jiang, PhD
Phone:
18980601096
Email:
jiang_chunling@yahoo.com
Start date:
April 20, 2024
Completion date:
October 20, 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06406244
