To investigate the effectiveness and cost-effectiveness of acupuncture treatment combined with standard care compared to standard care alone.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity
(FVC), the 2 scores combined as Forced Expiratory Ratio (FER=FEV/FVC),
reflecting the lung function
(2) Clinical COPD Questionnaire (CCQ), reflecting the overall health over the 3
domains, of symptoms/function/mental status.
Secondary outcome
(1) Physical endurance recorded in 6 Minute Walk Distance (6MWD)
(2) Inflammation factor (CRP)
(3) Cost-Effectiveness analysis
Background summary
Chronic obstructive pulmonary disease (COPD) and Asthma belong to major
disabling lung diseases worldwide. Due to smoking and aging, the COPD
(emphysema and chronic bronchitis) incidence will increase strongly in the near
future and as a consequence it will have a large impact on the Dutch Healthcare
costs. In the Netherlands, recently CAM-modalities are "mentioned" in the
National COPD-treatments guideline (LAN). The Dutch Medical Acupuncture Society
(NAAV) scientific committee has the intention to evaluate the additional value
of acupuncture treatment as performed within the context of the regular
GP-practices.
Study objective
To investigate the effectiveness and cost-effectiveness of acupuncture
treatment combined with standard care compared to standard care alone.
Study design
A 2-arm pragmatic randomised controlled multi-centre trial of 12 week
live-phase and 3 months follow-up time. The estimated sample size required to
detect an appropriate clinical difference at a power of 90 % and 5 %
significance is 100 participants. In order to mimic the *real-world* practice
blinding is not necessary, our data analysis will be an *Intention-to-Treat*
one.
Intervention
Patients allocated to the acupuncture group will receive the treatment at least
once a week for the following 12 weeks, in addition to taking
their daily medication. The control group will receive standard care only. All
regular activities, like taking exercises will not be interrupted.
Study burden and risks
Not applicable.
Springweg 7
Utrecht 3511 VH
NL
Springweg 7
Utrecht 3511 VH
NL
Listed location countries
Age
Inclusion criteria
COPD GOLD 1 and 2 categories lungpatients
Exclusion criteria
severe lung diseases
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41002.028.12 |