NCT03398213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 14, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 11, 2020

Completed
Last Updated

August 21, 2020

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

December 31, 2017

Results QC Date

June 23, 2020

Last Update Submit

August 13, 2020

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

  • 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)

    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 (7)

  • Duration of Hospitalization

    Through study completion, an average of 1 week

  • Carbon Dioxide Partial Pressure (pCO2)

    Day 1, day 2, day 3, and day 4 of the study

  • Power of Hydrogen (pH)

    Day 1, day 2, day 3, and day 4 of the study

  • Respiratory Rate

    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

    Day 1, day 2, day 3, and day 4 of the study

  • +2 more secondary outcomes

Study Arms (3)

Acupuncture

EXPERIMENTAL

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

Other: Acupuncture

Sham procedure

SHAM COMPARATOR

Ear stimulation with plaster + standard conventional care for COPD exacerbation

Other: Sham procedure

Standard care

NO INTERVENTION

Standard conventional care for COPD exacerbation

Interventions

AcupunctureOTHER

Acupuncture

Acupuncture
Sham procedureOTHER

Ear stimulation with plaster

Sham procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of COPD
  • Clinical diagnosis of acute exacerbation of COPD
  • Informed consent

You may not qualify if:

  • Hemodynamic instability
  • Platelet count \< 20 x 10\^9/L
  • Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bnai Zion Medical Center

Haifa, Golomb 47, 3104802, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 35579025DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Prof. Elad Schiff
Organization
Bnai Zion Medical Center
elad.schiff@b-zion.org.il
972-506267243

Study Officials

  • Elad Schiff, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2017

First Posted

January 12, 2018

Study Start

January 14, 2018

Primary Completion

December 25, 2019

Study Completion

March 1, 2020

Last Updated

August 21, 2020

Results First Posted

August 11, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)