COPDNCT04947800

Acupuncture to Enhance for Pulmonary Rehab

A study testing Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 and Pulmonary rehabilitation program + Lv7/Gb26 in people with COPD, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD
What is being tested?: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 and Pulmonary rehabilitation program + Lv7/Gb26
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 25 Jan 2022to 1 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Severe cognitive impairment
Active pulmonary exacerbation
Unstable cardiopulmonary disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: COPD
Being tested: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36, Pulmonary rehabilitation program + Lv7/Gb26
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36Device
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
Pulmonary rehabilitation program + Lv7/Gb26Device
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points

Study groups in NCT04947800
Study group	Role	What they receive
Arm A: 12 week intervention, 8 week control	Experimental	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. Receives: Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36; Device: Pulmonary rehabilitation program + Lv7/Gb26
Arm B: 8 week intervention, 12 week control	Experimental	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. Receives: Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36; Device: Pulmonary rehabilitation program + Lv7/Gb26
Arm C: 4 week intervention, 16 week control	Experimental	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. Receives: Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36; Device: Pulmonary rehabilitation program + Lv7/Gb26

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Forced Expiratory Volume in One Second (FEV1)
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Forced Vital Capacity (FVC)
Change in Forced vital capacity (FVC) as measures by spirometry test
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of Eosinophils
Change in number of eosinophils as measured in blood samples
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of Neutrophil
Change in number of neutrophil as measured in blood samples
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Number of C Reactive Protein
Change in number of C reactive protein as measured in blood samples
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Quality of Life Relating to Dyspnea as Measured by Borg Scales
The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in 6-minute Walk Distance
Change in maximum distance walked in 6 minutes
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Incidence of Acute Exacerbations (AE)
Throughout the course of the study acute exacerbations will be recorded and tallied.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20221 Jun 2024

First posted1 Jul 2021
Study start25 Jan 2022
Primary completion1 Jun 2024
Study completion1 Jun 2024

Why it stopped: 1\) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04947800
Sponsor's protocol ID: STUDY02000887
Status last verified: Sep 2025
First submitted: 23 Jun 2021
Last updated: 3 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring the Dose-Response Effect of Adjunctive Acupuncture on Pulmonary Rehabilitation: A Pilot Study
ClinicalTrials.gov ID: NCT04947800
Acronym / sponsor ID: STUDY02000887
Conditions: COPD
Study type: Interventional
Recruitment status: TerminatedReason stopped: 1\) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays
Enrolment: 13 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: American Academy of Medical Acupuncture
Study start: 25 Jan 2022 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 1 Jul 2021 (actual)
Results: Posted 3 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Arm A: 12 week intervention, 8 week control	Experimental	Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36, Device: Pulmonary rehabilitation program + Lv7/Gb26Electro 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.
Arm B: 8 week intervention, 12 week control	Experimental	Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36, Device: Pulmonary rehabilitation program + Lv7/Gb26Electro 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.
Arm C: 4 week intervention, 16 week control	Experimental	Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36, Device: Pulmonary rehabilitation program + Lv7/Gb26Electro 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

Severe cognitive impairment
Active pulmonary exacerbation
Unstable cardiopulmonary disease

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
Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points	Device	Arm A: 12 week intervention, 8 week control, Arm B: 8 week intervention, 12 week control, Arm C: 4 week intervention, 16 week control
Pulmonary rehabilitation program + Lv7/Gb26Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points	Device	Arm A: 12 week intervention, 8 week control, Arm B: 8 week intervention, 12 week control, Arm C: 4 week intervention, 16 week control

Primary outcome

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
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
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
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
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
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
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.
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.
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
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.

Results and safety

Results posted to the registry on 3 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: 12 week intervention, 8 week control	8	0
Arm B: 8 week intervention, 12 week control	0	0
Arm C: 4 week intervention, 16 week control	0	0

Primary outcome: Change in Forced Expiratory Volume in One Second (FEV1)

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Mean (Full Range). Unit: Liters

Measure	Arm A: 12 week intervention, 8 week control n = 8	Arm B: 8 week intervention, 12 week control n = 0	Arm C: 4 week intervention, 16 week control n = 0
Value	1.38 (.96 to 1.95)	–	–

Population analysed: Only baseline data was collected for Arm A. The study was closed before any data was collected for any other timepoints or Arms.

Primary outcome: Change in Forced Vital Capacity (FVC)

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Population analysed: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"

Primary outcome: Change in Number of Eosinophils

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Population analysed: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"

Primary outcome: Change in Number of Neutrophil

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Population analysed: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Arm A: 12 week intervention, 8 week control	0 of 0	0 of 0
Arm B: 8 week intervention, 12 week control	0 of 0	0 of 0
Arm C: 4 week intervention, 16 week control	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Institutional challenges with IRB and and cutting pulmonary rehab program prevented this trial from being completed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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. This study is not recruiting at the moment.

James E Stahl, MD, CM, MPH principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04947800.

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 3 Nov 2025.