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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 30min 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.

Patients in the sham group will receive electrode attachment but without stimulation.

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 30min 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.

transcutaneous electrical acupoint stimulation

sham transcutaneous electrical acupoint stimulation

Chunling Jiang, PhD

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain 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 30min 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.

Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups using a computer-generated random number table. After the randomization, use the opaque envelope, hide each group envelope into an opaque envelope, the envelope outside the code, will be sealed to the researcher, when the study, if the inclusion criteria, then open the corresponding numbered envelope, and intervene according to the group scheme in the envelope.

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.

Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

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

The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.

The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.

The pain is evaluated using numerical rating scale,NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain

Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator

We considered it PONV if patients felt any nausea or had any vomiting

Defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery

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)

Defined as the time to first defecation or time to first flatusdefined as the time to first defecation or time to first flatus defined as the time to first defecation or time to first flatus

Determined by the number of days from admittance to discharge

Postoperative sleep quality was 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 a diagnosis of insomnia.

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).

Patients were inquired whether they had any pain （NRS ≥ 1）in surgical area and if the pain developed postoperatively. If subjects answered with a 'no' to any of the two questions, those patients were classified as cases without CPSP. Contrarily, if subjects answered yes, they were considered CPSP cases.

West China Hospital

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Blood and Lymph Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Cancer Pain

Bone Neoplasms

Bone Marrow Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Analgesics

Immunomodulating Agents

A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side.

A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2Hz and stimulus current intensity in degrees as tolerated by the patient.

7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session.

A total of 4 sessions of treatment were administered.

Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial.

The patients are taken in the recumbent or sitting position, and the local skin at the acupoints is routinely disinfected. A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral acupoint group, so as contralateral side.

Transcutaneous electrical acupoint stimulation

The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.

Sham transcutaneous electrical acupoint stimulation

The patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on.

Routine palliative treatment

Yi Liang, PhD

Zhengyi Lyu, PhD

This multicenter, prospective, randomized controlled research study aims to objectively evaluate the role of transcutaneous electrical acupoint stimulation (TEAS), which combines the theory of acupuncture with transcutaneous electrical nerve stimulation (TENS) therapy, for the treatment of pain in patients with bone metastases from lung cancer.

TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer

Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study

According to the international consensus on palliative radiotherapy endpoints for bone metastasis clinical trials, the degree of therapeutic response for bone metastatic pain can be classified as complete response (CR: pain score of 0 and no increase in daily oral morphine equivalent dose (OMED) ), partial response (PR: ①pain score decrease of ≥ 2 and no increase in OMED; ②pain score no increase and decrease of ≥ 25% in OMED), pain progression (PP: ①≥ 2 increase in pain score with no decrease in OMED; ②≥ 1 increase in pain score with ≥ 25% increase in OMED) and indeterminate response (IR: cases not classified as CR / PR / PP).

Subjects in which complete or partial relief of pain was achieved were pain responders; Subjects whose pain progressed or was indeterminate response were non responders. The response rate of average pain = ((CR+PR) / No. of subjects) \*100%.

The daily oral morphine equivalent dose over the past 24 h will be recorded for both groups at each testing time point. Equivalent morphine dose conversions will be established in accordance with the NCCN clinical practice guidelines for adult cancer pain (version 3.2022). For instance, fentanyl transdermal patch (25 mcg/h) will be considered approximately equal to oxycodone (30 mg/d), parenteral morphine (20 mg/d), and oral morphine (60 mg/d).

The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) is an integrated system for assessing the quality of life (QoL) of cancer patients. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

HAM-D is a standardized scale for the measurement of the severity of depressive symptoms, initially designed to yield a total score based on 17 items. The scores of anxiety/depression and its change during the previous 2 weeks from baseline will be recorded.The total score \> 24 points, severe depression. 17≤ score ≤24, moderate depression. 7≤ score ≤17, mild depression. \< 7 points, no depressive symptoms.

HAM-A is one of the most widely used rating scales to measure the severity of perceived anxiety symptoms. A total of 14 items were included 14 items. The total score ≥29 points, may be severe anxiety. ≥21 points, there must be obvious anxiety. ≥14 points, must have anxiety. ≥7 points, may have anxiety. \< 7 points, no anxiety symptoms.

The Third Affiliated hospital of Zhejiang Chinese Medical University

Professor, Chief Chinese Medicine Practitioner

Behaviors and Mental Disorders

Quality of Life

transcutaneous acupoint electrical stimulation was performed at the bilateral Hegu and Waiguan acupoints for 30 minutes, and then transcutaneous acupoint electrical stimulation was performed at the Sanyinjiao and Zusanli acupoints of the bilateral lower limbs for 30 minutes.

Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS group

The 4 patches of the transcutaneous acupoint electrical stimulator were pasted on two pairs of acupuncture points, the output frequency was adjusted to 2Hz, the intensity was up to 50ma, the single intervention time was 30 minutes, and another group of acupuncture points was replaced after completion, and the rest of the operations were the same as above, with a total intervention time of 1 hour.

The patch is fixed on the acupuncture point to turn on the instrument, but there is no current output

sham Transcutaneous electrical acupoint stimulation

This is a randomized controlled clinical pilot study to evaluate the evidence-based basis for transcutaneous acupoint electrical stimulation to improve the quality of life of patients with cancer pain。

The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain

Patient-Controlled Transcutaneous Acupoint Electrical Stimulation to Improve Quality of Life in Patients With Cancer Pain

The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Overall health contains 2 questions and standardized scores with values ranging from 0 to 100. Higher scores indicate a better quality of life.

Karnofsky's performance status is a scale for evaluating the quality of life of patients. Scores range from 0 to 100, with higher scores indicating a better quality of life.

Brief Pain Inventory (BPI) scale is a commonly used scale for evaluating pain. Assess the patient's mean pain, severe pain, least pain score over the past week, and current level of pain. Scores range from 1-10, with higher scores indicating more severe pain.

Spontaneous bowel movements (SBM) refer to bowel movements that have occurred within the past 24 hours without the use of laxatives.Record the number of spontaneous bowel movements of the subject in the past week. Bowel Function Index (BFI) in clinical practice. Specially used to evaluate constipation caused by opioid drugs, the subject's difficulty in defecation and feeling of incomplete defecation in the past week will be recorded. The overall satisfaction rating of defecation.

The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Standardized scores with values ranging from 0 to 100. It 5 functional subscales including body, function, cognition, emotion, and Society. Functional subscales have higher scores with better health.

The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30) is a specific scale for the quality of life of cancer patients and contains 30 questions. Standardized scores with values ranging from 0 to 100. Symptom subscales including fatigue, pain, nausea, vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and economic difficulties. Symptom higher scores with worse health.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy	NCT06341270	Liver Cancer	transcutaneous ... sham transcutan...	18 Years - 80 Years	West China Hospital
TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer	NCT05730972	Cancer Pain Non Small Cell ... Bone Metastases Acupuncture	Transcutaneous ... Sham transcutan... Routine palliat...	18 Years - 80 Years	The Third Affiliated hospital of Zhejiang Chinese Medical University
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy	NCT06341270	Liver Cancer	transcutaneous ... sham transcutan...	18 Years - 80 Years	West China Hospital
The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain	NCT06188286	Cancer Pain	Transcutaneous ... sham Transcutan...	18 Years - 85 Years	The Third Affiliated hospital of Zhejiang Chinese Medical University
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy	NCT06341270	Liver Cancer	transcutaneous ... sham transcutan...	18 Years - 80 Years	West China Hospital
The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain	NCT06188286	Cancer Pain	Transcutaneous ... sham Transcutan...	18 Years - 85 Years	The Third Affiliated hospital of Zhejiang Chinese Medical University
TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer	NCT05730972	Cancer Pain Non Small Cell ... Bone Metastases Acupuncture	Transcutaneous ... Sham transcutan... Routine palliat...	18 Years - 80 Years	The Third Affiliated hospital of Zhejiang Chinese Medical University

Spots Global Cancer Trial Database for sham transcutaneous electrical acupoint stimulation