Acupuncture to Enhance for Pulmonary Rehab

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COPD

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: 12 week intervention, 8 week control<br>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<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points<br>Device: Pulmonary rehabilitation program + Lv7/Gb26<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points<br>|
| Experimental: Arm B: 8 week intervention, 12 week control<br>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<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points<br>Device: Pulmonary rehabilitation program + Lv7/Gb26<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points<br>|
| Experimental: Arm C: 4 week intervention, 16 week control<br>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<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points<br>Device: Pulmonary rehabilitation program + Lv7/Gb26<br>* Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |