NCT07287657

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 28, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

Video-assisted thoracoscopic surgery(VATS)Enhanced Recovery After Surgery(ERAS)pain, postoperativetranscutaneous electrical acupoint stimulationtranscutaneous electrical nerve stimulationacute painblood inflammatory biomarkersquality of lifeAnxiety and Depression

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)

    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 Outcomes (2)

  • Blood Inflammatory Markers

    Within 48 hours after surgery

  • Hospital Anxiety and Depression Scale

    At baseline (preoperative), and after surgery 6 and 48 hours later

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Participants receive standard postoperative analgesia according to institutional protocol.

Drug: Standard Analgesia

TENS Group

EXPERIMENTAL

Participants receive standard postoperative analgesia combined with transcutaneous electrical nerve stimulation (TENS)

Drug: Standard AnalgesiaDevice: Transcutaneous Electrical Nerve Stimulation (TENS)

TENS + TEAS Group

EXPERIMENTAL

Participants receive standard postoperative analgesia combined with both transcutaneous electrical nerve stimulation (TENS) and transcutaneous electrical acupoint stimulation (TEAS).

Drug: Standard AnalgesiaDevice: Transcutaneous Electrical Nerve Stimulation (TENS)Device: Transcutaneous Electrical Acupoint Stimulation (TEAS)

Interventions

Postoperative analgesic medications administered according to standard clinical practice and hospital guidelines

Control GroupTENS + TEAS GroupTENS Group

Non-invasive electrical nerve stimulation therapy applied to specific areas to reduce postoperative pain

TENS + TEAS GroupTENS Group

Electrical stimulation applied to specific acupuncture points through the skin to enhance analgesic efficacy and modulate autonomic function.

TENS + TEAS Group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People who are about to undergo thoracic surgery

You may not qualify if:

  • Patients with epilepsy,
  • Pacemaker installed
  • Severe infections status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital

Taipei, Hualien, 97002, Taiwan

Location

Related Publications (1)

  • Edwards DA, Hedrick TL, Jayaram J, Argoff C, Gulur P, Holubar SD, Gan TJ, Mythen MG, Miller TE, Shaw AD, Thacker JKM, McEvoy MD; POQI-4 Working Group. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Perioperative Management of Patients on Preoperative Opioid Therapy. Anesth Analg. 2019 Aug;129(2):553-566. doi: 10.1213/ANE.0000000000004018.

    PMID: 30768461BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAcute PainAnxiety DisordersDepression

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

December 17, 2025

Study Start

May 28, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 17, 2025

Record last verified: 2025-04

Locations