An interventional study of Acupuncture and Sham procedure in COPD Exacerbation, sponsored by Bnai Zion Medical Center. Completed at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-21.
Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Other: Acupuncture
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Other: Sham procedure
Standard conventional care for COPD exacerbation
Acupuncture
Ear stimulation with plaster
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
Duration of Hospitalization
Days of hospitalization
Time frame: Through study completion, an average of 1 week
Carbon Dioxide Partial Pressure (pCO2)
pCO2
Time frame: Day 1, day 2, day 3, and day 4 of the study
Power of Hydrogen (pH)
pH
Time frame: Day 1, day 2, day 3, and day 4 of the study
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
Oxygen Saturation
Oxygen saturation
Time frame: 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)
Time frame: 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)
Time frame: Day 1, day 2, day 3, and day 4 of the study
| Milestone | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Started | 26 | 24 | 22 |
| Completed | 26 | 24 | 22 |
| Not completed | 0 | 0 | 0 |
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)
| units on a scale | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Baseline | 8.0 (5.5 to 8.75) | 6.5 (5.0 to 8.5) | 7.75 (6.0 to 8.5) |
| Day 1 after treatment | 5 (4.0 to 5.0) | 6 (4.25 to 7.8) | 7 (5.5 to 8.0) |
| Day 2 before treatment | 5 (3.5 to 7) | 6.75 (5 to 8.5) | 7.5 (5.8 to 8.3) |
| Day 2 after treatment | 2 (1 to 3) | 5 (3 to 7) | 7.5 (5 to 8) |
| Day 3 before treatment | 2.5 (1 to 5) | 6 (4.5 to 7.3) | 5.75 (4.5 to 7) |
| Day 3 after treatment | 2 (1 to 3) | 6 (5 to 7) | 6 (2 to 7) |
| Day 4 before treatment | 3 (0 to 5) | 5.5 (3 to 8) | 7 (5 to 8.5) |
| Day 4 after treatment | 1 (0 to 3) | 5 (4 to 6) | 6 (5 to 7) |
Days of hospitalization
| days | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Duration of Hospitalization | 5.5 ± 2.3 | 6.0 ± 2.9 | 6.3 ± 2.9 |
pCO2
| Participants | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Day 1 — < 45 mmHg | 6 | 3 | 8 |
| Day 1 — 45-60 mmHg | 12 | 17 | 9 |
| Day 1 — 60-80 mmHg | 5 | 4 | 5 |
| Day 1 — > 80 mmHg | 3 | 0 | 0 |
| Day 2 — < 45 mmHg | 4 | 7 | 1 |
| Day 2 — 45-60 mmHg | 4 | 6 | 3 |
| Day 2 — 60-80 mmHg | 7 | 5 | 2 |
| Day 2 — > 80 mmHg | 3 | 1 | 2 |
| Day 3 — < 45 mmHg | 1 | 3 | 4 |
| Day 3 — 45-60 mmHg | 5 | 9 | 3 |
| Day 3 — 60-80 mmHg | 4 | 2 | 1 |
| Day 3 — > 80 mmHg | 2 | 1 | 1 |
| Day 4 — < 45 mmHg | 1 | 2 | 2 |
| Day 4 — 45-60 mmHg | 1 | 6 | 0 |
| Day 4 — 60-80 mmHg | 3 | 3 | 3 |
| Day 4 — > 80 mmHg | 1 | 0 | 1 |
pH
| Participants | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Day 1 — < 7.2 | 0 | 0 | 0 |
| Day 1 — 7.2-7.3 | 5 | 4 | 1 |
| Day 1 — > 7.3 | 21 | 20 | 21 |
| Day 2 — < 7.2 | 0 | 0 | 0 |
| Day 2 — 7.2-7.3 | 6 | 3 | 4 |
| Day 2 — > 7.3 | 12 | 16 | 4 |
| Day 3 — < 7.2 | 0 | 1 | 0 |
| Day 3 — 7.2-7.3 | 2 | 0 | 2 |
| Day 3 — > 7.3 | 7 | 14 | 7 |
| Day 4 — < 7.2 | 0 | 0 | 0 |
| Day 4 — 7.2-7.3 | 0 | 0 | 2 |
| Day 4 — > 7.3 | 6 | 11 | 4 |
Respiratory rate
| breaths per minute | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Baseline (day 1) | 21 (16 to 23.75) | 22 (16.5 to 26) | 20 (16 to 22) |
| Day 1 after treatment | 16 (14 to 20) | 18 (16 to 20.5) | 21 (18 to 26) |
| Day 2 before treatment | 18 (16 to 22) | 20 (16 to 25) | 22 (16 to 24) |
| Day 2 after treatment | 16 (12 to 16) | 18 (16 to 21.5) | 26 (21 to 30) |
| Day 3 before treatment | 16 (14 to 29) | 18 (16 to 24) | 18 (16 to 22) |
| Day 3 after treatment | 14 (12 to 20) | 16 (16 to 24) | 24 (18 to 24) |
| Day 4 before treatment | 16 (14 to 29) | 16 (16 to 23) | 18 (16 to 18) |
| Day 4 after treatment | 13 (12 to 17) | 16 (14 to 20) | 22 (18 to 26) |
Oxygen saturation
| Participants | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Day 1 — =< 80% | 4 | 1 | 0 |
| Day 1 — 81-89% | 9 | 10 | 10 |
| Day 1 — >= 90% | 13 | 13 | 12 |
| Day 2 — =< 80% | 2 | 4 | 2 |
| Day 2 — 81-89% | 10 | 10 | 5 |
| Day 2 — >= 90% | 12 | 10 | 12 |
| Day 3 — =< 80% | 0 | 3 | 0 |
| Day 3 — 81-89% | 10 | 7 | 6 |
| Day 3 — >= 90% | 9 | 13 | 11 |
| Day 4 — =< 80% | 1 | 0 | 0 |
| Day 4 — 81-89% | 4 | 3 | 2 |
| Day 4 — >= 90% | 6 | 14 | 12 |
Visual Analogue Scale (VAS) for cough (0- no cough, to 10- worse cough)
| units on a scale | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Day 1 | 7.5 (5.0 to 8.0) | 5.0 (5.0 to 7.3) | 5.0 (4 to 7.5) |
| Day 2 | 4.5 (1.5 to 5.5) | 5 (2.5 to 7.5) | 5 (4.5 to 7.5) |
| Day 3 | 3 (1 to 5) | 5 (3.3 to 7.3) | 5 (2.5 to 7.5) |
| Day 4 | 2.5 (2 to 4) | 4.5 (2.5 to 6) | 5 (0 to 7.5) |
Visual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum)
| units on a scale | Acupuncture | Sham Procedure | Standard Care |
|---|---|---|---|
| Day 1 | 6.0 (2 to 7.5) | 6.0 (4.5 to 6.0) | 5.0 (2.5 to 6.0) |
| Day 2 | 2.8 (1 to 4.5) | 5.5 (2 to 6) | 4.5 (2.5 to 5.5) |
| Day 3 | 2 (1 to 4) | 5 (3.5 to 6) | 4.5 (2.5 to 5) |
| Day 4 | 2 (1 to 4) | 5 (3 to 6) | 5 (2.5 to 6) |
Collected over 4 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acupuncture | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Sham Procedure | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Standard Care | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Acupuncture | Sham Procedure | Standard Care | Total |
|---|---|---|---|---|
| Mean | 69.2 ± 10.1 | 70.7 ± 8.1 | 67.4 ± 9.3 | 69.13 ± 9.2 |
| Sex: Female, Male(Participants) | Acupuncture | Sham Procedure | Standard Care | Total |
|---|---|---|---|---|
| Female | 6 | 9 | 5 | 20 |
| Male | 20 | 15 | 17 | 52 |
| Race and Ethnicity Not Collected(Participants) | Acupuncture | Sham Procedure | Standard Care | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Dyspnea intensity(units on a scale) | Acupuncture | Sham Procedure | Standard Care | Total |
|---|---|---|---|---|
| Median | 8 (5.5 to 8.75) | 6.5 (5 to 8.5) | 7.75 (6 to 8.5) | 7.5 (5 to 8.5) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bnai Zion Medical Center