Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations are a health-care burden involving frequent hospitalizations and elevated costs. They have effective therapies with significant side effects. Acupuncture has been shown to reduce dyspnea and other COPD-related symptoms. The investigators will compare the efficacy and safety of the addition of true acupuncture to usual care with both sham-acupressure added to usual care and usual care only for the treatment of acute exacerbations of COPD among inpatients.

Detailed Description
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This is an assessor-blinded randomized controlled trial in the setting of a tertiary academic medical center in Israel. Patients with clinical diagnosis of acute exacerbation of COPD will be randomized to either usual care only, usual care with true acupuncture or usual care with sham-acupressure. The primary outcome will be clinical improvement of dyspnea as measured by mBorg scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects will be evaluated by the validated Acupuncture Adverse Events (AcupAE) questionnaire.

Official Title
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Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous diagnosis of COPD Clinical diagnosis of acute exacerbation of COPD Informed consent Exclusion Criteria: Hemodynamic instability Platelet count < 20 x 10^9/L Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation | Other: Acupuncture<br>* Acupuncture<br>|
| Sham Comparator: Sham procedure<br>Ear stimulation with plaster + standard conventional care for COPD exacerbation | Other: Sham procedure<br>* Ear stimulation with plaster<br>|
| No Intervention: Standard care<br>Standard conventional care for COPD exacerbation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea Intensity | modified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea) | At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hospitalization | Days of hospitalization | Through study completion, an average of 1 week | 
| Carbon Dioxide Partial Pressure (pCO2) | pCO2 | Day 1, day 2, day 3, and day 4 of the study | 
| Power of Hydrogen (pH) | pH | Day 1, day 2, day 3, and day 4 of the study | 
| Respiratory Rate | Respiratory rate | At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment | 
| Oxygen Saturation | Oxygen saturation | Day 1, day 2, day 3, and day 4 of the study | 
| Cough Intensity | Visual Analogue Scale (VAS) for cough (0- no cough, to 10- worse cough) | Day 1, day 2, day 3, and day 4 of the study | 
| Sputum Intensity | Visual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum) | Day 1, day 2, day 3, and day 4 of the study |