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Completed

NCT Number: NCT03398213

Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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.

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Key information

Conditions

COPD Exacerbation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center, Haifa, Golomb 47, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Acupuncture

Sham Procedure

Other

Ear stimulation with plaster

Primary outcomes

  1. Dyspnea Intensity

    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

    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 outcomes

  1. Duration of Hospitalization

    Time frame: Through study completion, an average of 1 week

    Days of hospitalization

  2. Carbon Dioxide Partial Pressure (pCO2)

    Time frame: Day 1, day 2, day 3, and day 4 of the study

    pCO2

  3. Power of Hydrogen (pH)

    Time frame: Day 1, day 2, day 3, and day 4 of the study

    pH

  4. 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

    Respiratory rate

  5. Oxygen Saturation

    Time frame: Day 1, day 2, day 3, and day 4 of the study

    Oxygen saturation

  6. Cough Intensity

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 12, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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