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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Acupuncture
Ear stimulation with plaster
Bnai Zion Medical Center
Haifa, Golomb 47, Israel
Bnai Zion Medical Center
Haifa, Israel
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)
Time frame: 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
Duration of Hospitalization
Days of hospitalization
Time frame: Through study completion, an average of 1 week
Carbon Dioxide Partial Pressure (pCO2)
pCO2
Time frame: Day 1, day 2, day 3, and day 4 of the study
Power of Hydrogen (pH)
pH
Time frame: Day 1, day 2, day 3, and day 4 of the study
Respiratory Rate
Respiratory rate
Time frame: 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
Time frame: 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)
Time frame: 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)
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Time frame: Day 1, day 2, day 3, and day 4 of the study