Condition category
Respiratory
Date applied
11/02/2009
Date assigned
27/02/2009
Last edited
02/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jong-in Kim

ORCID ID

Contact details

483 Exporo Yuseng-gu
Daejeon
305-811
Korea
South
han8400@kiom.re.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KW0901

Study information

Scientific title

Acupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial

Acronym

Acupuncture for PER

Study hypothesis

The primary objective of the present protocol is to investigate the effectiveness of acupuncture in patients with moderate-severe persistent allergic rhinitis (PER) in Korea and China, compared to sham acupuncture and a no-acupuncture waitlist status.

Ethics approval

1. Kyung-Hee University Medical Center Ethics Committee gave approval on the 11th February 2009
2. Daegeon Oriental Hospital Ethics Committee gave approval on the 23rd January 2009

Study design

Multicentre randomised, subject and assessor blinded, sham acupuncture and waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Persistent allergic rhinitis

Intervention

The study includes the following periods in all groups: a run-in period of 1 week before randomisation, a treatment (acupuncture or sham) period of 4 weeks (3 sessions/week), and a follow-up period of 4 weeks.

Acupuncture group:
In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, LI20, ST2 and ST36, unilateral EX-1 and GV23) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 10 - 30 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two time manual stimulations, starting and ending point.

Sham acupuncture group:
The insertion sites will be 1 - 1.5 cm from the acupuncture points used for active acupuncture treatment and will be penetrated with the same type of acupuncture needles; the needle will be inserted to a depth of 3 - 5 mm with a perpendicular direction using hollow pool in a shallow needling technique to avoid de-qi. The needle is then rotated one time in order to preserve patient blinding.

Waitlist:
Participants who will be allocated to waitlist will receive no acupuncture or sham acupuncture treatments throughout the 4 weeks. After 4 weeks, if participants elect to try the acupuncture treatment, the active acupuncture treatment will be provided, acupuncture treatment period of 4 weeks (3 sessions/week).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up.

Secondary outcome measures

Measured after 12 sessions/4 weeks acupuncture treatment:
1. Rhinitis Quality of Life Questionnaire (RQLQ) score
2. Total non-nasal symptom score (i.e. headache, itching, pain, eye dropping)

Measured during follow-up period:
3. Quantity of conventional relief medication use

Overall trial start date

01/03/2009

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of PER, with moderate-severe or severe degree, according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA) initiative
2. Completed baseline AR diary and provided written informed consent
3. Aged greater than or equal to 18 years of age, either sex
4. Recruited from each centre by the use of local newspaper advertisements and posted notices at each site
5. Have had PER for greater than 4 days/week, and greater than 4 consecutive weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

233 participants, allowing for a 20% withdrawal rate

Participant exclusion criteria

1. Suffering serious medical conditions such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidaemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment
2. Congenital nasal abnormalities
3. Sinusitis or active asthma
4. Operation history
5. Received systemically administered corticosteroids within 6 months before enrolment
6. Received alternative and complementary modality, i.e. acupuncture or herbal medication for treating AR within 6 months

Topical oral and nasal H1 blockers, or corticosteroid, or nasal anti-cholinergic medication will be stopped before 1 week before enrolment.

Recruitment start date

01/03/2009

Recruitment end date

30/04/2010

Locations

Countries of recruitment

China, Korea, South

Trial participating centre

483 Exporo Yuseng-gu
Daejeon
305-811
Korea, South

Sponsor information

Organisation

Korea Institute of Oriental Medicine (South Korea)

Sponsor details

483 Exporo Yuseng-gu
Daejeon
305-811
Korea
South
smchoi@kiom.re.kr

Sponsor type

Research organisation

Website

http://www.kiom.re.kr

Funders

Funder type

Research organisation

Funder name

Korea Institute of Oriental Medicine (South Korea) - The Acupuncture, Moxibustion and Meridian Research Project (ref: K09050)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19602250
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23253122

Publication citations

  1. Protocol

    Kim JI, Lee MS, Jung SY, Choi JY, Lee S, Ko JM, Zhao H, Zhao J, Kim AR, Shin MS, Kang KW, Jung HJ, Kim TH, Liu B, Choi SM, Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol., Trials, 2009, 10, 54, doi: 10.1186/1745-6215-10-54.

  2. Results

    Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L, A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis., Allergy, 2013, 68, 3, 365-374, doi: 10.1111/all.12053.

Additional files

Editorial Notes