Lung NodulesNCT07443540
The Effect of Acupuncture on Pulmonary Function Recovery Following Lung Resection
A study testing Acupuncture Therapy and Incentive Spirometry (Standard Rehabilitation) in people with Lung Nodules, run by Chung Shan Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Nodules
- What is being tested?
- Acupuncture Therapy and Incentive Spirometry (Standard Rehabilitation)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lung Nodules
- Being tested
- Acupuncture Therapy, Incentive Spirometry (Standard Rehabilitation)
- Keywords
- Lung nodules, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TherapyProcedure or surgery
Acupuncture will be administered by certified practitioners.
Incentive Spirometry (Standard Rehabilitation)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupuncture Therapy; Device: 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. Receives: Device: Incentive Spirometry (Standard Rehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-surgery) and 1 week after surgery.
Secondary outcomes (2)
Postoperative Dyspnea Severity (Borg Scale)
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).
Measured: 1 week after surgery
Postoperative Pain Intensity (Numerical Rating Scale, NRS)
Assessed using the Numerical Rating Scale (NRS) for pain, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: Daily from postoperative day 1 through day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443540
- Sponsor's protocol ID
- CS2-25161
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Pulmonary Function Recovery Following Lung Resection: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07443540
- Acronym / sponsor ID
- CS2-25161
- Conditions
- Lung Nodules
- Keywords
- Lung nodules, acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus Standard Rehabilitation | Experimental | Procedure: Acupuncture Therapy, Device: Incentive Spirometry (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. |
| Standard Rehabilitation Alone | Active comparator | Device: Incentive Spirometry (Standard Rehabilitation)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture TherapyAcupuncture will be administered by certified practitioners. | Procedure or surgery | Acupuncture plus Standard Rehabilitation |
| Incentive Spirometry (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. | Device | Acupuncture plus Standard Rehabilitation, Standard Rehabilitation Alone |
Primary outcome
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.
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.
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.
2 secondary outcomes
Postoperative Dyspnea Severity (Borg Scale)
Time frame: 1 week after surgery
Postoperative Pain Intensity (Numerical Rating Scale, NRS)
Time frame: Daily from postoperative day 1 through day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Therapy and Incentive Spirometry (Standard Rehabilitation) in people with Lung Nodules, run by Chung Shan Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KUEN-WEI LIN, master (+886918432596, raymond22432596@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Forced Vital Capacity (FVC) (time frame: Baseline (pre-surgery) and 1 week after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.