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Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Primary Purpose

COPD Exacerbation

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Acupuncture
Sham procedure
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bnai Zion Medical Center
  • Bnai Zion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Acupuncture

Sham procedure

Standard care

Arm Description

Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation

Ear stimulation with plaster + standard conventional care for COPD exacerbation

Standard conventional care for COPD exacerbation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Duration of Hospitalization
Days of hospitalization
Carbon Dioxide Partial Pressure (pCO2)
pCO2
Power of Hydrogen (pH)
pH
Respiratory Rate
Respiratory rate
Oxygen Saturation
Oxygen saturation
Cough Intensity
Visual Analogue Scale (VAS) for cough (0- no cough, to 10- worse cough)
Sputum Intensity
Visual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum)

Full Information

First Posted
December 31, 2017
Last Updated
August 13, 2020
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03398213
Brief Title
Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Official Title
Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
December 25, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard conventional care for COPD exacerbation
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
Ear stimulation with plaster
Primary Outcome Measure Information:
Title
Dyspnea Intensity
Description
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
Secondary Outcome Measure Information:
Title
Duration of Hospitalization
Description
Days of hospitalization
Time Frame
Through study completion, an average of 1 week
Title
Carbon Dioxide Partial Pressure (pCO2)
Description
pCO2
Time Frame
Day 1, day 2, day 3, and day 4 of the study
Title
Power of Hydrogen (pH)
Description
pH
Time Frame
Day 1, day 2, day 3, and day 4 of the study
Title
Respiratory Rate
Description
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
Title
Oxygen Saturation
Description
Oxygen saturation
Time Frame
Day 1, day 2, day 3, and day 4 of the study
Title
Cough Intensity
Description
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
Title
Sputum Intensity
Description
Visual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum)
Time Frame
Day 1, day 2, day 3, and day 4 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Schiff, M.D.
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
State/Province
Golomb 47
ZIP/Postal Code
3104802
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35579025
Citation
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.
Results Reference
derived

Learn more about this trial

Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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