Effectiveness of Acupuncture for Asthma

This study has been completed.
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00917215
First received: June 9, 2009
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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)?


Condition Intervention
Asthma
Device: Disposable stainless steel acupuncture (0.2mmx4mm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial

Resource links provided by NLM:


Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00917215

Locations
Korea, Republic of
Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Korea Institute of Oriental Medicine
  More Information

No publications provided

Responsible Party: Sun-Mi Choi, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00917215     History of Changes
Other Study ID Numbers: KE0802
Study First Received: June 9, 2009
Last Updated: July 29, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Institute of Oriental Medicine:
Asthma
Acupuncture
Pulmonary function
Quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014