Clinical trial NCT03398213: 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
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dyspnea Intensity
timeFrame: 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 outcomes:
measure: Duration of Hospitalization
timeFrame: Through study completion, an average of 1 week
measure: Carbon Dioxide Partial Pressure (pCO2)
timeFrame: Day 1, day 2, day 3, and day 4 of the study
measure: Power of Hydrogen (pH)
timeFrame: Day 1, day 2, day 3, and day 4 of the study
measure: Respiratory Rate
timeFrame: 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: Oxygen Saturation
timeFrame: Day 1, day 2, day 3, and day 4 of the study
measure: Cough Intensity
timeFrame: Day 1, day 2, day 3, and day 4 of the study
measure: Sputum Intensity
timeFrame: Day 1, day 2, day 3, and day 4 of the study
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
state: Golomb 47
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Elad Schiff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.