Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: Acupuncture; Other: Sham procedure

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Bnai Zion Medical Center
  • Golomb 47
    • Haifa, Golomb 47, Israel, 3104802
      • Bnai Zion Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Publications and helpful links

General Publications

• Levy I, Elimeleh Y, Gavrieli S, Attias S, Schiff A, Oliven A, Schiff E. Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial. Acupunct Med. 2022 Dec;40(6):505-515. doi: 10.1177/09645284221086293. Epub 2022 May 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2018
• Primary Completion (Actual): December 25, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 31, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 0108-17-BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No