Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398213
• Other study ID #: 0108-17-BNZ
• Status: Completed
• Phase: N/A
• Start date: January 14, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2019
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 1, 2020
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Acupuncture
Acupuncture
• Sham procedure
Ear stimulation with plaster

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa	Golomb 47
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Hospitalization	Days of hospitalization	Through study completion, an average of 1 week
Secondary	Carbon Dioxide Partial Pressure (pCO2)	pCO2	Day 1, day 2, day 3, and day 4 of the study
Secondary	Power of Hydrogen (pH)	pH	Day 1, day 2, day 3, and day 4 of the study
Secondary	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
Secondary	Oxygen Saturation	Oxygen saturation	Day 1, day 2, day 3, and day 4 of the study
Secondary	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
Secondary	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