Acupuncture to Enhance for Pulmonary Rehab

October 7, 2025 updated by: James E. Stahl, Dartmouth-Hitchcock Medical Center

Exploring the Dose-Response Effect of Adjunctive Acupuncture on Pulmonary Rehabilitation: A Pilot Study

The investigator is investigating if acupuncture may improve pulmonary function, exercise tolerance, stress and modulate the inflammatory effects of chronic obstructive pulmonary disease (COPD). The investigator would like to measure the effect of the combination of acupuncture with standard pulmonary rehab in patients with COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participation in this study may last 3 months. The experimental intervention is electro-acupuncture. Electro-acupuncture is similar to Transcutaneous Electrical Nerve Stimulation (TENS) where a very small current of electricity is applied, in this case to specific acupuncture points. The intervention will be applied by a trained physician-acupuncturist. The treatment itself would be applied for 20 minutes prior to regularly scheduled pulmonary rehab session. All participants will receive electro-acupuncture for the duration of the study. Because the investigators are interested in the effect of dose, participants will be randomized to 4, 8 or 12 weeks of "active pulmonary" acupuncture versus "control" acupuncture. One third of the participants will be asked to undergo the intervention for 4 weeks, one third will be asked to undergo the intervention for 8 weeks and one third will be asked to undergo the intervention for 12 weeks. Intervention acupuncture needles will be placed on what are thought to be active points for helping lung function, control acupuncture needles will be placed in neutral locations. Participants will not be told which weeks they are receiving the active acupuncture versus the control. Information relating to pulmonary and physical function, standard blood markers of inflammation, and survey responses at the beginning, during and after the intervention will be collected. During the experimental period participants will be asked to fill out surveys on quality of life, pulmonary function and physical function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Qualify to participate in the pulmonary rehab program at DHMC

Exclusion Criteria:

  • Severe cognitive impairment
  • Active pulmonary exacerbation
  • Unstable cardiopulmonary disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: 12 week intervention, 8 week control
Electro acupuncture (EA) intervention will be administered for 12 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 8 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function.
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
Device: Pulmonary rehabilitation program + Lv7/Gb26
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points
Experimental: Arm B: 8 week intervention, 12 week control
Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function.
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
Device: Pulmonary rehabilitation program + Lv7/Gb26
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points
Experimental: Arm C: 4 week intervention, 16 week control
Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function.
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
Device: Pulmonary rehabilitation program + Lv7/Gb26
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Acute Exacerbations (AE)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Throughout the course of the study acute exacerbations will be recorded and tallied.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced Expiratory Volume in One Second (FEV1)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced Vital Capacity (FVC)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced vital capacity (FVC) as measures by spirometry test
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of Eosinophils
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of eosinophils as measured in blood samples
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of Neutrophil
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of neutrophil as measured in blood samples
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of C Reactive Protein
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in number of C reactive protein as measured in blood samples
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Quality of Life Relating to Dyspnea as Measured by Borg Scales
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Health Related Quality of Life as Measured by the St. George's Respiratory Questionnaire
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The St. George's Respiratory Questionnaire scores range from 0 to 100, with higher scores indicating more limitations. The 50-item questionnaire was developed to measure health status (quality of life) in patients with diseases of airways obstruction.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Health Related Quality of Life as Measure by the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The Patient Health Questionnaire-9 scale questionnaire measures the level of depression. Score range is 0 to 27 points. Higher scores mean more severe depression.
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in 6-minute Walk Distance
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in maximum distance walked in 6 minutes
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Academy of Medical Acupuncture

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James E Stahl, MD, CM, MPH, Dartmouth-Hitchcock Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY02000887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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