Acupuncture for Persistent Allergic Rhinitis
| ISRCTN | ISRCTN90807007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90807007 |
| Protocol serial number | KW0901 |
| Sponsor | Korea Institute of Oriental Medicine (South Korea) |
| Funder | Korea Institute of Oriental Medicine (South Korea) - The Acupuncture, Moxibustion and Meridian Research Project (ref: K09050) |
- 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
Scientific
483 Exporo Yuseng-gu
Daejeon
305-811
Korea, South
| han8400@kiom.re.kr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised, subject and assessor blinded, sham acupuncture and waitlist controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Acupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial |
| Study acronym | Acupuncture for PER |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Changes in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up. |
| Key secondary outcome measure(s) |
Measured after 12 sessions/4 weeks acupuncture treatment: |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 233 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- China
- Korea, South
Study participating centre
483 Exporo Yuseng-gu
Daejeon
305-811
Korea, South
305-811
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Protocol article | protocol | 14/07/2009 | Yes | No |
