- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443540
The Effect of Acupuncture on Pulmonary Function Recovery Following Lung Resection
The Effect of Acupuncture on Pulmonary Function Recovery Following Lung Resection: A Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung resection surgery is the standard diagnostic and therapeutic approach for patients with early-stage lung adenocarcinoma. However, removal of part of the lung inevitably leads to a reduction in lung volume. In addition, postoperative pain often limits respiratory movement, resulting in impaired pulmonary function recovery. Therefore, rehabilitation strategies are essential to help maintain and restore cardiopulmonary capacity following surgery. According to current clinical guidelines, the most commonly recommended rehabilitation methods include structured cardiopulmonary training and adequate perioperative analgesia. Other supportive interventions, such as physical therapy and alternative exercise programs, have also been explored in recent clinical studies, with varying levels of effectiveness. Given the steadily increasing number of patients undergoing lung resection each year, the development and evaluation of additional therapeutic strategies to enhance postoperative pulmonary rehabilitation are of growing importance.
Acupuncture has been widely applied in the management of respiratory diseases and in perioperative pain control. Evidence from clinical studies supports its therapeutic effect in conditions such as asthma and chronic obstructive pulmonary disease (COPD). In patients with COPD, acupuncture has been shown to improve pulmonary function and quality of life. Furthermore, research has demonstrated that acupuncture can play a role in reducing postoperative pain and enhancing recovery. Despite these findings, a review of the literature indicates that no studies have yet specifically evaluated the efficacy of acupuncture in postoperative rehabilitation among patients who have undergone lung resection. Considering that lung cancer has been included in integrative oncology outpatient programs in traditional Chinese medicine, the potential role of acupuncture as an adjunct to rehabilitation after lung resection warrants systematic investigation.
This study is designed as a randomized controlled clinical trial. Patients in the control group will receive the current standard rehabilitation program, which consists of lung volume training with incentive spirometry following lung resection surgery. Patients in the intervention group will receive the same rehabilitation protocol with the addition of acupuncture therapy. Pulmonary function tests will be conducted one week after surgery in both groups to assess and compare postoperative outcomes. The primary endpoint will be the improvement of lung function parameters, while secondary outcomes will include pain levels, patient-reported quality of life, and tolerability of the intervention.
Through this design, the study aims to provide high-quality clinical evidence regarding the effectiveness of acupuncture in enhancing postoperative pulmonary rehabilitation after lung resection. The findings are expected to contribute to the development of integrative treatment strategies, offering patients improved recovery pathways that combine evidence-based conventional methods with traditional therapies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KUEN-WEI LIN, master
- Phone Number: +886918432596
- Email: raymond22432596@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupuncture plus Standard Rehabilitation
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.
|
Acupuncture will be administered by certified practitioners.
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.
|
|
Active Comparator: Standard Rehabilitation Alone
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Forced Vital Capacity (FVC)
Time Frame: Baseline (pre-surgery) and 1 week after surgery.
|
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)
Time Frame: Baseline (pre-surgery) and 1 week after surgery.
|
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)
Time Frame: Baseline (pre-surgery) and 1 week after surgery.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Dyspnea Severity (Borg Scale)
Time Frame: 1 week after surgery
|
Assessed using the Modified Borg Scale to evaluate the severity of shortness of breath.
The scale ranges from 0 (no breathlessness at all) to 10 (maximal breathlessness).
|
1 week after surgery
|
|
Postoperative Pain Intensity (Numerical Rating Scale, NRS)
Time Frame: Daily from postoperative day 1 through day 7
|
Assessed using the Numerical Rating Scale (NRS) for pain, where 0 indicates no pain and 10 indicates the worst possible pain.
|
Daily from postoperative day 1 through day 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS2-25161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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