Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Not Applicable

Completed

• Conditions: COPD Exacerbation
• Interventions: Other: Acupuncture; Other: Sham procedure

• Registration Number: NCT03398213
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-12-31
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Study Start: 2018-01-14
• Status Verified: 2019-06
• Primary Completion: 2019-12-25
• Study Completion: 2020-03-01
• Results First Submitted: 2020-06-23
• Results First Submitted QC: 2020-07-21
• Results First Posted: 2020-08-11
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Previous diagnosis of COPD
• Clinical diagnosis of acute exacerbation of COPD
• Informed consent

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Exclusion Criteria

• Hemodynamic instability
• Platelet count < 20 x 10^9/L
• Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Sham procedure	Sham procedure	Ear stimulation with plaster + standard conventional care for COPD exacerbation

Primary Outcome Measures

Name	Time	Method
Dyspnea Intensity	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	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel