Acupuncture to Enhance for Pulmonary Rehab

NCT04947800 | Terminated Results FDA Device

• 1 other identifier: STUDY02000887
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Study Arms (3)

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.

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.

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.

Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36; Device: Pulmonary rehabilitation program + Lv7/Gb26

Interventions

Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 DEVICE

Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points

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/Gb26 DEVICE

Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points

Arm A: 12 week intervention, 8 week control; Arm B: 8 week intervention, 12 week control; Arm C: 4 week intervention, 16 week control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• American Academy of Medical Acupuncture: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Institutional challenges with IRB and and cutting pulmonary rehab program prevented this trial from being completed

Results Point of Contact

• Title: james stahl
• Organization: Dartmouth-Hitchcock

james.e.stahl@hitchcock.org

6036502000

Study Officials

• James E Stahl, MD, CM, MPH

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which weeks they are receiving the active acupuncture versus the control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Staff Physician, General Internal Medicine

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: January 25, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)