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Acupuncture to Enhance for Pulmonary Rehab

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Dartmouth Health

Status

Terminated

Conditions

COPD

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04947800
STUDY02000887

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

13 participants in 3 patient groups

Arm A: 12 week intervention, 8 week control
Experimental group
Description:
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.
Treatment:
Device: Pulmonary rehabilitation program + Lv7/Gb26
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Arm B: 8 week intervention, 12 week control
Experimental group
Description:
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.
Treatment:
Device: Pulmonary rehabilitation program + Lv7/Gb26
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36
Arm C: 4 week intervention, 16 week control
Experimental group
Description:
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.
Treatment:
Device: Pulmonary rehabilitation program + Lv7/Gb26
Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36

Trial documents
1

Trial contacts and locations

1

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Central trial contact

James E Stahl, MD, CM, MPH

Data sourced from clinicaltrials.gov

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