Acupuncture for Persistent Allergic Rhinitis

ISRCTN ISRCTN90807007
DOI https://doi.org/10.1186/ISRCTN90807007
Secondary identifying numbers KW0901
Submission date
11/02/2009
Registration date
27/02/2009
Last edited
02/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jong-in Kim
Scientific

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

han8400@kiom.re.kr

Study information

Study designMulticentre randomised, subject and assessor blinded, sham acupuncture and waitlist controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAcupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial
Study acronymAcupuncture for PER
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedPersistent allergic rhinitis
InterventionThe 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 typeOther
Primary outcome measureChanges in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up.
Secondary outcome measuresMeasured 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 study start date01/03/2009
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants233 participants, allowing for a 20% withdrawal rate
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/03/2009
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • China
  • Korea, South

Study participating centre

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

Sponsor information

Korea Institute of Oriental Medicine (South Korea)
Research organisation

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

smchoi@kiom.re.kr
http://www.kiom.re.kr
ROR logo https://ror.org/005rpmt10

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 14/07/2009 Yes No
Results article results 01/03/2013 Yes No
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