Acupuncture to Enhance for Pulmonary Rehab

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: Terminated
• Conditions: COPD
• Intervention / Treatment: Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36; Device: Pulmonary rehabilitation program + Lv7/Gb26

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: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of Acute Exacerbations (AE)	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)	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)	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	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	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	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	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	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)	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	Change in maximum distance walked in 6 minutes	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: American Academy of Medical Acupuncture
• Investigators: Principal Investigator: James E Stahl, MD, CM, MPH, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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