Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03398213
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arms: 3
• Actual Duration (Months): 25.5
• Patients Per Site: 36
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation	Other: Acupuncture; Other: Sham procedure	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial
• Actual Study Start Date: Jan 14, 2018
• Actual Primary Completion Date: Dec 25, 2019
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Duration of Hospitalization [Through study completion, an average of 1 week]

   Days of hospitalization

2. Carbon Dioxide Partial Pressure (pCO2) [Day 1, day 2, day 3, and day 4 of the study]

   pCO2

3. Power of Hydrogen (pH) [Day 1, day 2, day 3, and day 4 of the study]

   pH

4. 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

5. Oxygen Saturation [Day 1, day 2, day 3, and day 4 of the study]

   Oxygen saturation

6. 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)

7. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion Medical Center	Haifa	Golomb 47	Israel	3104802
2	Bnai Zion Medical Center	Haifa		Israel

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

• Principal Investigator: Elad Schiff, M.D., Bnai Zion Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 3, 2020

More Information

Publications

None provided.

• Responsible Party: Bnai Zion Medical Center
• ClinicalTrials.gov Identifier: NCT03398213
• Other Study ID Numbers: 0108-17-BNZ
• First Posted: Jan 12, 2018
• Last Update Posted: Aug 21, 2020
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture N=26	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster N=24	Standard conventional care for COPD exacerbation N=22
Period Title: Overall Study
STARTED	26	24	22
COMPLETED	26	24	22
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care	Total
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation	Total of all reporting groups
Overall Participants	26	24	22	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (10.1)	70.7 (8.1)	67.4 (9.3)	69.13 (9.2)
Sex: Female, Male (Count of Participants)
Female	6 23.1%	9 37.5%	5 22.7%	20 27.8%
Male	20 76.9%	15 62.5%	17 77.3%	52 72.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Dyspnea intensity (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	8	6.5	7.75	7.5

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
Baseline	8.0	6.5	7.75
Day 1 after treatment	5	6	7
Day 2 before treatment	5	6.75	7.5
Day 2 after treatment	2	5	7.5
Day 3 before treatment	2.5	6	5.75
Day 3 after treatment	2	6	6
Day 4 before treatment	3	5.5	7
Day 4 after treatment	1	5	6

2. Secondary Outcome

Title	Duration of Hospitalization
Description	Days of hospitalization
Time Frame	Through study completion, an average of 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
Mean (Standard Deviation) [days]	5.5 (2.3)	6.0 (2.9)	6.3 (2.9)

3. Secondary Outcome

Title	Carbon Dioxide Partial Pressure (pCO2)
Description	pCO2
Time Frame	Day 1, day 2, day 3, and day 4 of the study

Outcome Measure Data

Analysis Population Description

Blood gases were not taken daily to all participants

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
< 45 mmHg	6 23.1%	3 12.5%	8 36.4%
45-60 mmHg	12 46.2%	17 70.8%	9 40.9%
60-80 mmHg	5 19.2%	4 16.7%	5 22.7%
> 80 mmHg	3 11.5%	0 0%	0 0%
< 45 mmHg	4 15.4%	7 29.2%	1 4.5%
45-60 mmHg	4 15.4%	6 25%	3 13.6%
60-80 mmHg	7 26.9%	5 20.8%	2 9.1%
> 80 mmHg	3 11.5%	1 4.2%	2 9.1%
< 45 mmHg	1 3.8%	3 12.5%	4 18.2%
45-60 mmHg	5 19.2%	9 37.5%	3 13.6%
60-80 mmHg	4 15.4%	2 8.3%	1 4.5%
> 80 mmHg	2 7.7%	1 4.2%	1 4.5%
< 45 mmHg	1 3.8%	2 8.3%	2 9.1%
45-60 mmHg	1 3.8%	6 25%	0 0%
60-80 mmHg	3 11.5%	3 12.5%	3 13.6%
> 80 mmHg	1 3.8%	0 0%	1 4.5%

4. Secondary Outcome

Title	Power of Hydrogen (pH)
Description	pH
Time Frame	Day 1, day 2, day 3, and day 4 of the study

Outcome Measure Data

Analysis Population Description

Blood gases were not measured daily in all participants

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
< 7.2	0 0%	0 0%	0 0%
7.2-7.3	5 19.2%	4 16.7%	1 4.5%
> 7.3	21 80.8%	20 83.3%	21 95.5%
< 7.2	0 0%	0 0%	0 0%
7.2-7.3	6 23.1%	3 12.5%	4 18.2%
> 7.3	12 46.2%	16 66.7%	4 18.2%
< 7.2	0 0%	1 4.2%	0 0%
7.2-7.3	2 7.7%	0 0%	2 9.1%
> 7.3	7 26.9%	14 58.3%	7 31.8%
< 7.2	0 0%	0 0%	0 0%
7.2-7.3	0 0%	0 0%	2 9.1%
> 7.3	6 23.1%	11 45.8%	4 18.2%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
Baseline (day 1)	21	22	20
Day 1 after treatment	16	18	21
Day 2 before treatment	18	20	22
Day 2 after treatment	16	18	26
Day 3 before treatment	16	18	18
Day 3 after treatment	14	16	24
Day 4 before treatment	16	16	18
Day 4 after treatment	13	16	22

6. Secondary Outcome

Title	Oxygen Saturation
Description	Oxygen saturation
Time Frame	Day 1, day 2, day 3, and day 4 of the study

Outcome Measure Data

Analysis Population Description

Oxygen saturation is missing for some participants in days 2, 3 and 4

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
=< 80%	4 15.4%	1 4.2%	0 0%
81-89%	9 34.6%	10 41.7%	10 45.5%
>= 90%	13 50%	13 54.2%	12 54.5%
=< 80%	2 7.7%	4 16.7%	2 9.1%
81-89%	10 38.5%	10 41.7%	5 22.7%
>= 90%	12 46.2%	10 41.7%	12 54.5%
=< 80%	0 0%	3 12.5%	0 0%
81-89%	10 38.5%	7 29.2%	6 27.3%
>= 90%	9 34.6%	13 54.2%	11 50%
=< 80%	1 3.8%	0 0%	0 0%
81-89%	4 15.4%	3 12.5%	2 9.1%
>= 90%	6 23.1%	14 58.3%	12 54.5%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
Day 1	7.5	5.0	5.0
Day 2	4.5	5	5
Day 3	3	5	5
Day 4	2.5	4.5	5

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acupuncture	Sham Procedure	Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture	Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster	Standard conventional care for COPD exacerbation
Measure Participants	26	24	22
Day 1	6.0	6.0	5.0
Day 2	2.8	5.5	4.5
Day 3	2	5	4.5
Day 4	2	5	5

Adverse Events

Time Frame	4 days
Arm/Group Title	Acupuncture		Sham Procedure		Standard Care
Arm/Group Description	Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture		Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster		Standard conventional care for COPD exacerbation
All Cause Mortality
	Acupuncture		Sham Procedure		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/24 (0%)		0/22 (0%)
Serious Adverse Events
	Acupuncture		Sham Procedure		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/24 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Acupuncture		Sham Procedure		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/24 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.