Effectiveness of Acupuncture for Asthma

NCT00917215 | Completed

• 1 other identifier: KE0802
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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)?

Conditions

Asthma

Keywords

Asthma; Acupuncture; Pulmonary function; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change of weekly average of peak expiratory flow (PEF)values in the morning at home

  From 1 week of run-in period to the 4th week of treatment

Secondary Outcomes (1)

• Forced expiratory volume in 1 second (FEV1) Baseline Dyspnea Index (BDI) Transition Dyspnea Index (TDI) Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA)

  Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline)

Study Arms (3)

Active acupuncture

EXPERIMENTAL

Device: Disposable stainless steel acupuncture (0.2mmx4mm)

Sham acupuncture

SHAM COMPARATOR

Device: Disposable stainless steel acupuncture (0.2mmx4mm)

Waiting list control

NO INTERVENTION

Interventions

Disposable stainless steel acupuncture (0.2mmx4mm) DEVICE

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.

Active acupuncture; Sham acupuncture

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead

Study Sites (1)

Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center

Seoul, 130-702, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 10, 2009
• Study Start: September 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

KR (1)