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Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

B

Bnai Zion Medical Center

Status

Completed

Conditions

COPD Exacerbation

Treatments

Other: Sham procedure
Other: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03398213
0108-17-BNZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 3 patient groups

Acupuncture
Experimental group
Description:
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Treatment:
Other: Acupuncture
Sham procedure
Sham Comparator group
Description:
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Treatment:
Other: Sham procedure
Standard care
No Intervention group
Description:
Standard conventional care for COPD exacerbation

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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