Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery

At present, surgical resection remains one of the main methods for the radical treatment of lung cancer. Compared with traditional thoracotomy, Video-assisted Thoracoscopic Surgery (VATS) offers obvious advantages, such as less surgical trauma and rapid postoperative recovery. However, a certain proportion of patients will still experience moderate to severe pain after undergoing VATS. Postoperative acute pain can lead to increased postoperative pulmonary complications, prolonged hospital stays, and increased treatment costs. Additionally, it is also associated with the development of postoperative chronic pain. Therefore, effective pain management after VATS is crucial.

Researchers will compare Transcutaneous Electrical Nerve Stimulation (TENS) based on Wrist-Ankle Acupuncture theory (TENS-WAA) with a sham stimulation regimen to determine whether TENS-WAA can relieve postoperative pain in patients undergoing thoracoscopic lung resection. This study aims to enrich the existing postoperative analgesia schemes and provide a reliable basis for its clinical promotion.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Video-assisted Thoracoscopic Surgery (VATS)
• Intervention / Treatment: Device: TENS-WAA; Device: Sham (No Treatment)

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200090
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged over 18 years
• American Society of Anesthesiologists (ASA) physical status of I-III
• Patients scheduled for elective unilateral lobectomy via video-assisted thoracoscopic surgery (VATS) for lung cancer under general anesthesia
• Informed consent signed

Exclusion Criteria:

• History of liver, kidney, heart, lung, or brain disease
• Psychiatric disorder or cognitive impairment
• Chronic pain, daily use of analgesics, or alcohol dependence
• Routine or recent acupuncture treatment
• Contraindications to TENS (with pacemaker or metallic implants, allergy to surface electrodes, with skin sensory disorders, skin ulceration, unhealed scars, or adhesions)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS-WAA group; Patients assigned to the TENS-WAA group will receive transcutaneous electrical nerve stimulation (TENS) based on Wrist-Ankle Acupuncture theory (WAA) for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively.	Device: TENS-WAA; Patients assigned to the TENS-WAA group will receive transcutaneous electrical nerve stimulation based on Wrist-Ankle Acupuncture theory for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. According to the principles of WAA, two pairs of TENS-WAA (Wuxi Jiajian Medical Device Co., Ltd.) electrode pads will be placed on the upper area 2 and 3 with the skin of the treatment area exposed, and the upper and lower juxtaposition method will be adopted. Upper area 2 is at the middle of the palmar side of the forearm, between the palmaris longus and flexor carpi radialis. Upper area 3 is between the edge of the radius and the radial artery. Stimulation parameters of TENS-WAA are alternating dense-disperse wave with a frequency of 2Hz and a pulse width of 200μs, and a frequency of 100Hz with a pulse width of 150μs, alternating every 3 seconds ，intensity required to reach the maximum tolerable level without causing pain.
Sham Comparator: sham TENS-WAA group; Patients assigned to the sham TENS-WAA group will receive sham stimulation （without stimulation）for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively.	Device: Sham (No Treatment); Patients assigned to the sham TENS-WAA group will receive sham stimulation for a duration of 30 minutes after anesthesia induction, as well as at 8 hours and 24 hours postoperatively. Researchers will attach the electrode patches at the same location, set the parameters to the same frequency, pulse width, and minimum current intensity as the TENS-WAA group, but do not activate the device, leaving it in place for 30 minutes at each time point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dynamic VAS score	Independent investigators will assess the postoperative dynamic pain (pain during activities or coughing) by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.	at 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The static VAS score	Postoperative static pain (pain at rest) will be quantified using the VAS.	at 6 hours, 12 hours, 24 hours and 48 hours after surgery
The dynamic VAS score	Postoperative dynamic pain (pain during activities or coughing) will be quantified using the VAS.	at 6 hours, 12 hours and 48 hours after surgery
Opioid consumption during surgery	The consumption of opioids during the surgery will be converted into morphine equivalent, and then the total will be calculated.	at the end of the surgery
Postoperative opioid consumption	The consumption of opioids within 48 hours after surgery will be converted into morphine equivalent.	at 48 hours after surgery
Consumption of NSAIDs	The consumption of Non-steroidal Anti-inflammatory Drugs within 48 hours after surgery will be recorded.	at 48 hours after surgery
The 15-item QoR score	The 15-item QoR score is used to assess the quality of recovery after surgery, which ranges from 0 to 150, and higher QoR-15 scores indicate better postoperative recovery.	at 24 hours and 48 hours after surgery
The HADS score	The Hospital Anxiety and Depression Scale (HADS) is used to evaluate patients' anxiety and depression. Scores on the HADS range from 0 to 21, and higher scores indicate more severe anxiety or depression.	at 24 hours and 48 hours after surgery
The AIS score	The Athens Insomnia Scale (AIS) is used to assess the quality of sleep after surgery. Scores on the AIS range from 0 to 24, and higher scores indicate worse sleep quality.	The morning of the first day after surgery and the morning of the second day after surgery.
Incidence of PONV	The researchers will observe whether patients experience nausea and vomiting after surgery.	at 48 hours after surgery
The duration of hospital stay	The period from the end of surgery to the patient's discharge from the hospital will be recorded.	on the 1 day of the patient's discharge from the hospital

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jiafeng Wang, M.D., Changhai hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Video-assisted thoracoscopic surgery (VATS)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: TENS-WAA-VATS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No