Effectiveness of Acupuncture for Asthma

July 29, 2009 updated by: Korea Institute of Oriental Medicine

Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial

What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF) variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment (waiting list control group)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 130-702
        • Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 19-70 years
  • at least 12% improvement in forced expiratory volume in one second (FEV1)after the administration of short acting beta2 agonist.
  • at least one typical asthmatic symptom
  • using more than one routine anti-asthmatic medicine

Exclusion Criteria:

  • acupuncture for asthma within 12 months of the study
  • emergency department visit within one month of the study
  • hospitalization for asthma within three months of the study
  • severe upper respiratory tract infections within six weeks of the study
  • systemic infections, cancers, autoimmune disorders, cardiac failures, myofacial infarcts,angina pectoris, renal failures or hepato-biliary diseases
  • smoke more than ten cigarettes per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham acupuncture
Device: Disposable stainless steel acupuncture (0.2mmx4mm)

For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.

For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.
No Intervention: Waiting list control
Experimental: Active acupuncture
Device: Disposable stainless steel acupuncture (0.2mmx4mm)

For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.

For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of weekly average of peak expiratory flow (PEF)values in the morning at home
Time Frame: From 1 week of run-in period to the 4th week of treatment
From 1 week of run-in period to the 4th week of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in 1 second (FEV1) Baseline Dyspnea Index (BDI) Transition Dyspnea Index (TDI) Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA)
Time Frame: Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline)
Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Institute of Oriental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2009

Last Update Submitted That Met QC Criteria

July 29, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Disposable stainless steel acupuncture (0.2mmx4mm)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe