Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

NCT ID: NCT03398213

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-14
• Study Completion Date: 2020-03-01

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.

Conditions

COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acupuncture

Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture

Sham procedure

Ear stimulation with plaster + standard conventional care for COPD exacerbation

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: OTHER

Ear stimulation with plaster

Standard care

Standard conventional care for COPD exacerbation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Acupuncture

Intervention Type: OTHER

Sham procedure

Ear stimulation with plaster

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elad Schiff, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Locations

Bnai Zion Medical Center

Haifa, Golomb 47, Israel

Bnai Zion Medical Center

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 35579025 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0108-17-BNZ

Identifier Type: -

Identifier Source: org_study_id