- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287657
Exploring the Effects of Transcutaneous Electrical Acupoint Stimulation Therapy on Patients After Video-Assisted Thoracoscopic Surgery
December 3, 2025 updated by: Buddhist Tzu Chi General Hospital
Exploring the Impact of Transcutaneous Electrical Acupoint Stimulation Therapy on Postoperative Pain, Quality of Life, and Blood Inflammatory Markers in Lung Cancer Patients After Video Assisted Thoracoscopic Surgery
Thoracic surgery is known to be one of the most painful types of surgery.
If acute postoperative pain is not properly managed, there is a high risk that it may develop into clinically significant chronic pain within six months after surgery, which can seriously affect quality of life.
According to research on Enhanced Recovery After Surgery (ERAS), using multimodal pain management strategies can significantly reduce postoperative pain and decrease reliance on pain medications.
This study aims to investigate whether combining transcutaneous Electrical Nerve Stimulation therapy with conventional pain management can further enhance pain relief and improve recovery outcomes.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
This study aims to evaluate the efficacy of three postoperative analgesic strategies in patients undergoing lesion resection via video-assisted thoracoscopic surgery (VATS).
Under standard postoperative care protocols, patients will be randomized into three groups: (1) conventional pharmacologic analgesia alone, (2) conventional analgesia combined with transcutaneous electrical nerve stimulation (TENS), and (3) conventional analgesia combined with both transcutaneous electrical nerve stimulation (TENS) and transcutaneous electrical acupoint stimulation (TEAS).
The primary outcomes include the assessment of acute postoperative pain intensity, blood inflammatory biomarkers, health-related quality of life, and the incidence of postoperative complications.
This investigation seeks to determine whether adjunctive use of neuromodulatory techniques such as TENS and TEAS can enhance analgesic efficacy and improve postoperative recovery profiles.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hualien
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Taipei, Hualien, Taiwan, 97002
- Hualien Tzu Chi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- People who are about to undergo thoracic surgery
Exclusion Criteria:
- Patients with epilepsy,
- Pacemaker installed
- Severe infections status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Participants receive standard postoperative analgesia according to institutional protocol.
|
Postoperative analgesic medications administered according to standard clinical practice and hospital guidelines
|
|
Experimental: TENS Group
Participants receive standard postoperative analgesia combined with transcutaneous electrical nerve stimulation (TENS)
|
Postoperative analgesic medications administered according to standard clinical practice and hospital guidelines
Non-invasive electrical nerve stimulation therapy applied to specific areas to reduce postoperative pain
|
|
Experimental: TENS + TEAS Group
Participants receive standard postoperative analgesia combined with both transcutaneous electrical nerve stimulation (TENS) and transcutaneous electrical acupoint stimulation (TEAS).
|
Postoperative analgesic medications administered according to standard clinical practice and hospital guidelines
Non-invasive electrical nerve stimulation therapy applied to specific areas to reduce postoperative pain
Electrical stimulation applied to specific acupuncture points through the skin to enhance analgesic efficacy and modulate autonomic function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time Frame: Within 48 hours after surgery
|
Pain intensity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
|
Within 48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Inflammatory Markers
Time Frame: Within 48 hours after surgery
|
Blood inflammatory markers, including the neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR), will be calculated using complete blood count (CBC) parameters.
NLR increases are commonly interpreted as indicators of elevated systemic inflammation, whereas decreases in LMR may reflect enhanced inflammatory activity or physiological stress following surgery.
These ratios will be assessed at multiple perioperative time points to evaluate changes in inflammatory response.
The relationship between postoperative pain levels, clinical recovery, and changes in NLR and LMR will be analyzed to determine whether inflammatory activation is associated with greater postoperative pain or adverse outcomes.
Units of measure are expressed as ratios (NLR, LMR).
|
Within 48 hours after surgery
|
|
Hospital Anxiety and Depression Scale
Time Frame: At baseline (preoperative), and after surgery 6 and 48 hours later
|
The Hospital Anxiety and Depression Scale (HADS) will be used to evaluate participants' psychological status during the perioperative period.
The scale consists of 14 items, with 7 items assessing anxiety (HADS-A) and 7 items assessing depression (HADS-D).
Each item is scored from 0 to 3, yielding subscale scores ranging from 0 to 21.
Higher scores indicate greater levels of anxiety or depression.
Changes in HADS-A and HADS-D scores will be analyzed to determine postoperative psychological responses and the potential impact of different analgesic interventions.
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At baseline (preoperative), and after surgery 6 and 48 hours later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
April 28, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Behavioral Symptoms
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain, Postoperative
- Anxiety Disorders
- Depression
- Acute Pain
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Analgesia
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- Lin,Chun-Ya
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Because it is still underway, I will share it after the research is completed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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