COPD Exacerbation
Conditions
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.
Interventions
OTHERAcupuncture
Acupuncture
OTHERSham procedure
Ear stimulation with plaster
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Carbon Dioxide Partial Pressure (pCO2) | Day 1, day 2, day 3, and day 4 of the study | pCO2 |
| Power of Hydrogen (pH) | Day 1, day 2, day 3, and day 4 of the study | pH |
| 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 |
| Duration of Hospitalization | Through study completion, an average of 1 week | Days of hospitalization |
| 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) |
| 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) |
| Oxygen Saturation | Day 1, day 2, day 3, and day 4 of the study | Oxygen saturation |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture | 26 |
| Sham Procedure Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster | 24 |
| Standard Care Standard conventional care for COPD exacerbation | 22 |
| Total | 72 |
Baseline characteristics
| Characteristic | Acupuncture | Sham Procedure | Standard Care | Total |
|---|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 10.1 | 70.7 years STANDARD_DEVIATION 8.1 | 67.4 years STANDARD_DEVIATION 9.3 | 69.13 years STANDARD_DEVIATION 9.2 |
| Dyspnea intensity | 8 units on a scale | 6.5 units on a scale | 7.75 units on a scale | 7.5 units on a scale |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 17 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 0 / 26 | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 22 |
Outcome results
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)
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Dyspnea Intensity | Baseline | 8.0 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 1 after treatment | 5 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 2 before treatment | 5 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 2 after treatment | 2 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 3 before treatment | 2.5 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 3 after treatment | 2 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 4 before treatment | 3 units on a scale |
| Acupuncture | Dyspnea Intensity | Day 4 after treatment | 1 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 2 before treatment | 6.75 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 4 before treatment | 5.5 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 2 after treatment | 5 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 3 before treatment | 6 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 3 after treatment | 6 units on a scale |
| Sham Procedure | Dyspnea Intensity | Baseline | 6.5 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 1 after treatment | 6 units on a scale |
| Sham Procedure | Dyspnea Intensity | Day 4 after treatment | 5 units on a scale |
| Standard Care | Dyspnea Intensity | Day 2 before treatment | 7.5 units on a scale |
| Standard Care | Dyspnea Intensity | Day 1 after treatment | 7 units on a scale |
| Standard Care | Dyspnea Intensity | Baseline | 7.75 units on a scale |
| Standard Care | Dyspnea Intensity | Day 2 after treatment | 7.5 units on a scale |
| Standard Care | Dyspnea Intensity | Day 4 before treatment | 7 units on a scale |
| Standard Care | Dyspnea Intensity | Day 3 after treatment | 6 units on a scale |
| Standard Care | Dyspnea Intensity | Day 3 before treatment | 5.75 units on a scale |
| Standard Care | Dyspnea Intensity | Day 4 after treatment | 6 units on a scale |
Secondary
Carbon Dioxide Partial Pressure (pCO2)
pCO2
Time frame: Day 1, day 2, day 3, and day 4 of the study
Population: Blood gases were not taken daily to all participants
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | < 45 mmHg | 4 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 45-60 mmHg | 12 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 60-80 mmHg | 5 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | > 80 mmHg | 3 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | < 45 mmHg | 6 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 45-60 mmHg | 4 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 60-80 mmHg | 7 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | > 80 mmHg | 3 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | < 45 mmHg | 1 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 45-60 mmHg | 5 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 60-80 mmHg | 4 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | > 80 mmHg | 2 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | < 45 mmHg | 1 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 45-60 mmHg | 1 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 60-80 mmHg | 3 Participants |
| Acupuncture | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | > 80 mmHg | 1 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 45-60 mmHg | 6 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 60-80 mmHg | 5 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | > 80 mmHg | 1 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 45-60 mmHg | 6 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | < 45 mmHg | 3 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 45-60 mmHg | 9 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | > 80 mmHg | 0 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 60-80 mmHg | 2 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | < 45 mmHg | 3 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 60-80 mmHg | 3 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 45-60 mmHg | 17 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | > 80 mmHg | 1 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 60-80 mmHg | 4 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | > 80 mmHg | 0 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | < 45 mmHg | 7 Participants |
| Sham Procedure | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | < 45 mmHg | 2 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 60-80 mmHg | 1 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 45-60 mmHg | 3 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | < 45 mmHg | 2 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 60-80 mmHg | 5 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | 60-80 mmHg | 2 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | > 80 mmHg | 1 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | < 45 mmHg | 8 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | > 80 mmHg | 2 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | > 80 mmHg | 1 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 2 | < 45 mmHg | 1 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | < 45 mmHg | 4 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 45-60 mmHg | 0 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | 45-60 mmHg | 9 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 3 | 45-60 mmHg | 3 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 1 | > 80 mmHg | 0 Participants |
| Standard Care | Carbon Dioxide Partial Pressure (pCO2) | Day 4 | 60-80 mmHg | 3 Participants |
Secondary
Cough Intensity
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Cough Intensity | Day 1 | 7.5 units on a scale |
| Acupuncture | Cough Intensity | Day 2 | 4.5 units on a scale |
| Acupuncture | Cough Intensity | Day 3 | 3 units on a scale |
| Acupuncture | Cough Intensity | Day 4 | 2.5 units on a scale |
| Sham Procedure | Cough Intensity | Day 4 | 4.5 units on a scale |
| Sham Procedure | Cough Intensity | Day 1 | 5.0 units on a scale |
| Sham Procedure | Cough Intensity | Day 3 | 5 units on a scale |
| Sham Procedure | Cough Intensity | Day 2 | 5 units on a scale |
| Standard Care | Cough Intensity | Day 4 | 5 units on a scale |
| Standard Care | Cough Intensity | Day 2 | 5 units on a scale |
| Standard Care | Cough Intensity | Day 3 | 5 units on a scale |
| Standard Care | Cough Intensity | Day 1 | 5.0 units on a scale |
Secondary
Duration of Hospitalization
Days of hospitalization
Time frame: Through study completion, an average of 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Duration of Hospitalization | 5.5 days | Standard Deviation 2.3 |
| Sham Procedure | Duration of Hospitalization | 6.0 days | Standard Deviation 2.9 |
| Standard Care | Duration of Hospitalization | 6.3 days | Standard Deviation 2.9 |
Secondary
Oxygen Saturation
Oxygen saturation
Time frame: Day 1, day 2, day 3, and day 4 of the study
Population: Oxygen saturation is missing for some participants in days 2, 3 and 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Acupuncture | Oxygen Saturation | Day 1 | =< 80% | 4 Participants |
| Acupuncture | Oxygen Saturation | Day 1 | 81-89% | 9 Participants |
| Acupuncture | Oxygen Saturation | Day 1 | >= 90% | 13 Participants |
| Acupuncture | Oxygen Saturation | Day 2 | =< 80% | 2 Participants |
| Acupuncture | Oxygen Saturation | Day 2 | 81-89% | 10 Participants |
| Acupuncture | Oxygen Saturation | Day 2 | >= 90% | 12 Participants |
| Acupuncture | Oxygen Saturation | Day 3 | =< 80% | 0 Participants |
| Acupuncture | Oxygen Saturation | Day 3 | 81-89% | 10 Participants |
| Acupuncture | Oxygen Saturation | Day 3 | >= 90% | 9 Participants |
| Acupuncture | Oxygen Saturation | Day 4 | =< 80% | 1 Participants |
| Acupuncture | Oxygen Saturation | Day 4 | 81-89% | 4 Participants |
| Acupuncture | Oxygen Saturation | Day 4 | >= 90% | 6 Participants |
| Sham Procedure | Oxygen Saturation | Day 4 | >= 90% | 14 Participants |
| Sham Procedure | Oxygen Saturation | Day 1 | =< 80% | 1 Participants |
| Sham Procedure | Oxygen Saturation | Day 3 | =< 80% | 3 Participants |
| Sham Procedure | Oxygen Saturation | Day 3 | >= 90% | 13 Participants |
| Sham Procedure | Oxygen Saturation | Day 1 | 81-89% | 10 Participants |
| Sham Procedure | Oxygen Saturation | Day 2 | >= 90% | 10 Participants |
| Sham Procedure | Oxygen Saturation | Day 4 | 81-89% | 3 Participants |
| Sham Procedure | Oxygen Saturation | Day 1 | >= 90% | 13 Participants |
| Sham Procedure | Oxygen Saturation | Day 3 | 81-89% | 7 Participants |
| Sham Procedure | Oxygen Saturation | Day 2 | 81-89% | 10 Participants |
| Sham Procedure | Oxygen Saturation | Day 2 | =< 80% | 4 Participants |
| Sham Procedure | Oxygen Saturation | Day 4 | =< 80% | 0 Participants |
| Standard Care | Oxygen Saturation | Day 2 | =< 80% | 2 Participants |
| Standard Care | Oxygen Saturation | Day 2 | 81-89% | 5 Participants |
| Standard Care | Oxygen Saturation | Day 4 | =< 80% | 0 Participants |
| Standard Care | Oxygen Saturation | Day 2 | >= 90% | 12 Participants |
| Standard Care | Oxygen Saturation | Day 3 | =< 80% | 0 Participants |
| Standard Care | Oxygen Saturation | Day 3 | 81-89% | 6 Participants |
| Standard Care | Oxygen Saturation | Day 4 | 81-89% | 2 Participants |
| Standard Care | Oxygen Saturation | Day 1 | =< 80% | 0 Participants |
| Standard Care | Oxygen Saturation | Day 1 | 81-89% | 10 Participants |
| Standard Care | Oxygen Saturation | Day 3 | >= 90% | 11 Participants |
| Standard Care | Oxygen Saturation | Day 1 | >= 90% | 12 Participants |
| Standard Care | Oxygen Saturation | Day 4 | >= 90% | 12 Participants |
Secondary
Power of Hydrogen (pH)
pH
Time frame: Day 1, day 2, day 3, and day 4 of the study
Population: Blood gases were not measured daily in all participants
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Acupuncture | Power of Hydrogen (pH) | Day 2 | 7.2-7.3 | 6 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 1 | 7.2-7.3 | 5 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 3 | 7.2-7.3 | 2 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 2 | > 7.3 | 12 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 1 | < 7.2 | 0 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 3 | < 7.2 | 0 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 4 | 7.2-7.3 | 0 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 1 | > 7.3 | 21 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 4 | < 7.2 | 0 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 2 | < 7.2 | 0 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 4 | > 7.3 | 6 Participants |
| Acupuncture | Power of Hydrogen (pH) | Day 3 | > 7.3 | 7 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 1 | > 7.3 | 20 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 1 | < 7.2 | 0 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 1 | 7.2-7.3 | 4 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 2 | < 7.2 | 0 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 2 | 7.2-7.3 | 3 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 2 | > 7.3 | 16 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 3 | < 7.2 | 1 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 3 | 7.2-7.3 | 0 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 3 | > 7.3 | 14 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 4 | < 7.2 | 0 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 4 | 7.2-7.3 | 0 Participants |
| Sham Procedure | Power of Hydrogen (pH) | Day 4 | > 7.3 | 11 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 2 | < 7.2 | 0 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 4 | 7.2-7.3 | 2 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 3 | > 7.3 | 7 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 1 | > 7.3 | 21 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 1 | < 7.2 | 0 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 4 | < 7.2 | 0 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 2 | > 7.3 | 4 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 1 | 7.2-7.3 | 1 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 3 | < 7.2 | 0 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 2 | 7.2-7.3 | 4 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 4 | > 7.3 | 4 Participants |
| Standard Care | Power of Hydrogen (pH) | Day 3 | 7.2-7.3 | 2 Participants |
Secondary
Respiratory Rate
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Respiratory Rate | Baseline (day 1) | 21 breaths per minute |
| Acupuncture | Respiratory Rate | Day 1 after treatment | 16 breaths per minute |
| Acupuncture | Respiratory Rate | Day 2 before treatment | 18 breaths per minute |
| Acupuncture | Respiratory Rate | Day 2 after treatment | 16 breaths per minute |
| Acupuncture | Respiratory Rate | Day 3 before treatment | 16 breaths per minute |
| Acupuncture | Respiratory Rate | Day 3 after treatment | 14 breaths per minute |
| Acupuncture | Respiratory Rate | Day 4 before treatment | 16 breaths per minute |
| Acupuncture | Respiratory Rate | Day 4 after treatment | 13 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 2 before treatment | 20 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 4 before treatment | 16 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 2 after treatment | 18 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 3 before treatment | 18 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 3 after treatment | 16 breaths per minute |
| Sham Procedure | Respiratory Rate | Baseline (day 1) | 22 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 1 after treatment | 18 breaths per minute |
| Sham Procedure | Respiratory Rate | Day 4 after treatment | 16 breaths per minute |
| Standard Care | Respiratory Rate | Day 2 before treatment | 22 breaths per minute |
| Standard Care | Respiratory Rate | Day 1 after treatment | 21 breaths per minute |
| Standard Care | Respiratory Rate | Baseline (day 1) | 20 breaths per minute |
| Standard Care | Respiratory Rate | Day 2 after treatment | 26 breaths per minute |
| Standard Care | Respiratory Rate | Day 4 before treatment | 18 breaths per minute |
| Standard Care | Respiratory Rate | Day 3 after treatment | 24 breaths per minute |
| Standard Care | Respiratory Rate | Day 3 before treatment | 18 breaths per minute |
| Standard Care | Respiratory Rate | Day 4 after treatment | 22 breaths per minute |
Secondary
Sputum Intensity
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Acupuncture | Sputum Intensity | Day 1 | 6.0 units on a scale |
| Acupuncture | Sputum Intensity | Day 2 | 2.8 units on a scale |
| Acupuncture | Sputum Intensity | Day 3 | 2 units on a scale |
| Acupuncture | Sputum Intensity | Day 4 | 2 units on a scale |
| Sham Procedure | Sputum Intensity | Day 4 | 5 units on a scale |
| Sham Procedure | Sputum Intensity | Day 1 | 6.0 units on a scale |
| Sham Procedure | Sputum Intensity | Day 3 | 5 units on a scale |
| Sham Procedure | Sputum Intensity | Day 2 | 5.5 units on a scale |
| Standard Care | Sputum Intensity | Day 4 | 5 units on a scale |
| Standard Care | Sputum Intensity | Day 2 | 4.5 units on a scale |
| Standard Care | Sputum Intensity | Day 3 | 4.5 units on a scale |
| Standard Care | Sputum Intensity | Day 1 | 5.0 units on a scale |