NCT07443540

Brief Summary

Background and Purpose: Lung resection surgery is the standard treatment for early-stage lung adenocarcinoma, but it often leads to reduced lung volume and postoperative pain, which can hinder pulmonary recovery. While standard rehabilitation includes breathing exercises (incentive spirometry) and pain management, additional strategies are needed to enhance recovery. Acupuncture has shown benefits in managing respiratory diseases like COPD and reducing surgical pain, but its specific effectiveness in rehabilitation after lung resection has not yet been established. This study aims to evaluate whether adding acupuncture to standard postoperative care can further improve lung function and recovery. Study Design and Methods: This is a randomized controlled clinical trial. Participants who have undergone lung resection will be assigned to one of two groups: Control Group: Receives standard rehabilitation (lung volume training with incentive spirometry). Intervention Group: Receives standard rehabilitation plus acupuncture therapy. Evaluation: One week after surgery, researchers will perform pulmonary function tests on all participants. The study will compare the two groups primarily based on improvements in lung function. Secondary outcomes, including pain levels and quality of life, will also be assessed to determine the overall benefit and safety of integrating acupuncture into postoperative recovery.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

March 2, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

Lung nodulesacupuncture

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in Forced Vital Capacity (FVC)

    The change in Forced Vital Capacity (FVC), measured in liters, from the preoperative baseline to 1 week after surgery.

    Baseline (pre-surgery) and 1 week after surgery.

  • Change from Baseline in Forced Expiratory Volume in 1 second (FEV1)

    The change in FEV1, measured in liters, from the preoperative baseline to 1 week after surgery.

    Baseline (pre-surgery) and 1 week after surgery.

  • Change from Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCo)

    The change in DLCo (measured in mL/min/mmHg) from the preoperative baseline to 1 week after surgery, to assess the gas exchange efficiency of the lungs.

    Baseline (pre-surgery) and 1 week after surgery.

Secondary Outcomes (2)

  • Postoperative Dyspnea Severity (Borg Scale)

    1 week after surgery

  • Postoperative Pain Intensity (Numerical Rating Scale, NRS)

    Daily from postoperative day 1 through day 7

Study Arms (2)

Acupuncture plus Standard Rehabilitation

EXPERIMENTAL

Participants in this group will receive acupuncture therapy in addition to the standard postoperative rehabilitation program. Standard rehabilitation includes lung volume training with incentive spirometry. Acupuncture sessions will be administered following lung resection surgery.

Procedure: Acupuncture TherapyDevice: Incentive Spirometry (Standard Rehabilitation)

Standard Rehabilitation Alone

ACTIVE COMPARATOR

Participants in this group will receive the current standard rehabilitation program, consisting of lung volume training with incentive spirometry following lung resection surgery. No acupuncture therapy will be administered.

Device: Incentive Spirometry (Standard Rehabilitation)

Interventions

Acupuncture will be administered by certified practitioners.

Acupuncture plus Standard Rehabilitation

Postoperative lung volume training using an incentive spirometer. Participants are instructed to perform deep breathing exercises multiple times a day as per current clinical guidelines for lung resection recovery.

Acupuncture plus Standard RehabilitationStandard Rehabilitation Alone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients aged between 18 and 65 years.
  • Diagnosed with a single pulmonary lesion (e.g., solitary pulmonary nodule or adenocarcinoma in situ).
  • Scheduled to undergo elective wedge resection for the lung lesion.

You may not qualify if:

  • History of prior lung resection.
  • Medical history of asthma or pulmonary tuberculosis.
  • History of pneumothorax prior to the current surgery.
  • Expectation to receive rehabilitation therapies other than the standard protocol-defined incentive spirometry during the study period.
  • Presence of other major systemic diseases (e.g., severe cardiovascular, renal, or hepatic impairment) that, in the investigator's opinion, render the patient unsuitable for trial participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

KUEN-WEI LIN, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a two-arm, randomized, controlled, open-label trial. Participants are randomly assigned in a 1:1 ratio to either the intervention group (acupuncture plus standard rehabilitation) or the control group (standard rehabilitation alone). The study evaluates the efficacy of acupuncture as an adjunct therapy for postoperative pulmonary rehabilitation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

March 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

To protect the privacy of study participants and maintain data confidentiality in accordance with institutional review board (IRB) policies, there is no plan to share individual participant data with external researchers.