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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation |
|
| Sham procedure | Sham Comparator | Ear stimulation with plaster + standard conventional care for COPD exacerbation |
|
| Standard care | No Intervention | Standard conventional care for COPD exacerbation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Acupuncture |
| |
| Sham procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Days of hospitalization | Through study completion, an average of 1 week |
| Carbon Dioxide Partial Pressure (pCO2) | pCO2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elad Schiff, M.D. | Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Haifa | Golomb 47 | 3104802 | Israel | ||
| Bnai Zion Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35579025 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture N=26 |
| FG001 | Sham Procedure | Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster N=24 |
| FG002 | Standard Care | Standard conventional care for COPD exacerbation N=22 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture |
| BG001 | Sham Procedure | Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Median | Inter-Quartile Range | units on a scale | 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 |
|
4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Acupuncture: Acupuncture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Elad Schiff | Bnai Zion Medical Center | 972-506267243 | elad.schiff@b-zion.org.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2020 | Jul 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Other |
Ear stimulation with plaster |
|
| 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 |
| Haifa |
| Israel |
| BG002 | Standard Care | Standard conventional care for COPD exacerbation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Dyspnea intensity | Median | Inter-Quartile Range | units on a scale |
|
| OG002 | Standard Care | Standard conventional care for COPD exacerbation |
|
|
| Secondary | Duration of Hospitalization | Days of hospitalization | Posted | Mean | Standard Deviation | days | Through study completion, an average of 1 week |
|
|
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| Secondary | Carbon Dioxide Partial Pressure (pCO2) | pCO2 | Blood gases were not taken daily to all participants | Posted | Count of Participants | Participants | Day 1, day 2, day 3, and day 4 of the study |
|
|
|
| Secondary | Power of Hydrogen (pH) | pH | Blood gases were not measured daily in all participants | Posted | Count of Participants | Participants | Day 1, day 2, day 3, and day 4 of the study |
|
|
|
| Secondary | Respiratory Rate | Respiratory rate | Posted | Median | Inter-Quartile Range | breaths per minute | 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 | Oxygen saturation is missing for some participants in days 2, 3 and 4 | Posted | Count of Participants | Participants | 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) | Posted | Median | Inter-Quartile Range | units on a scale | 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) | Posted | Median | Inter-Quartile Range | units on a scale | Day 1, day 2, day 3, and day 4 of the study |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Sham Procedure | Ear stimulation with plaster + standard conventional care for COPD exacerbation Sham procedure: Ear stimulation with plaster | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Standard Care | Standard conventional care for COPD exacerbation | 0 | 22 | 0 | 22 | 0 | 22 |
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| Male |
|
| 45-60 mmHg |
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| 60-80 mmHg |
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| > 80 mmHg |
|
| Day 2 |
|
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| Day 3 |
|
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| Day 4 |
|
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| 7.2-7.3 |
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| > 7.3 |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 2 before treatment |
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| Day 2 after treatment |
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| Day 3 before treatment |
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| Day 3 after treatment |
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| Day 4 before treatment |
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| Day 4 after treatment |
|
| 81-89% |
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| >= 90% |
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| Day 2 |
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| Day 3 |
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| Day 4 |
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| Day 3 |
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| Day 4 |
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| Day 3 |
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| Day 4 |
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