Acupuncture for treating Persistent Allergic Rhinitis with comorbid Chronic Maxillary Sinusitis

ISRCTN	ISRCTN80312467
DOI	https://doi.org/10.1186/ISRCTN80312467
Secondary identifying numbers	KI0901

Submission date: 06/03/2009
Registration date: 16/03/2009
Last edited: 01/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jung Won Kang
Scientific

Korea Institute of Oriental Medicine
483 Exporo Yuseong-gu
Daejeon
305-811
Korea, South

Email	drkang@kiom.re.kr

Study information

Study design	Double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Acupuncture for treating Persistent Allergic Rhinitis with comorbid Chronic Maxillary Sinusitis: a randomised sham-controlled pilot trial
Study acronym	Acupuncture for PER with CMS
Study objectives	This study is aimed to test the feasibility of a randomised sham-controlled clinical trial regarding efficacy and safety of acupuncture treatment for comorbid state of persistent allergic rhinitis (PER) and non-infectious chronic maxillary sinusitis (CMS).
Ethics approval(s)	Daegeon Oriental Hospital Ethics Committee, approved on 23/01/2009.
Health condition(s) or problem(s) studied	Allergic rhinosinusitis
Intervention	This is a randomised, subject and assessor blinded, sham acupuncture controlled trial. Participants will receive active or sham acupuncture treatment 3 times per week for 4 weeks and will be followed up for 4 weeks by specialists in traditional Korean medicine. Treatment sites for active acupuncture treatment: Six local (facial) and 4 distant acupoints from face were selected. Facial acupoints are EX-1, GV23, LI20 (bilateral), ST2 (bilateral) and distant acupoints are left-sided acupoints of LU9, SP3, LU10 and HT8. Treatment sites for sham acupuncture treatment: Non acupoints matched with and adjacent to acupoints in active acupuncture group
Intervention type	Other
Primary outcome measure	Daily total nasal symptom score (TNSS) of participants recorded on diaries. TNSS is a summation of four nasal symptom scores graded by 5-point-Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). These nasal symptoms are nasal obstruction, rhinorrhea, sneezing and pruritus. Weekly average of daily TNSS from 1 week before treatment initiation to 8th week of study will be calculated and analysed. Primary endpoint will be between the duration of 1 week before treatment initiation and the last (4th) week of active or sham acupuncture treatment.
Secondary outcome measures	1. Change in paranasal X-ray. Timepoints of assessment: baseline, 4 weeks and 8 weeks after baseline 2. Rhinitis Quality of Life Questionnaire (RQLQ) score. Timepoints of assessment: baseline, 4 weeks and 8 weeks after baseline 3. Total non-nasal symptom score (i.e. headache, itching, pain, eye dropping) of which grading method is the same as TNSS. Timepoints of assessment: from -1st week (run-in period) of baseline to the 8th week after baseline. Weekly average of daily total non-nasal symptom score will be observed.
Overall study start date	09/03/2009
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	This trial will be carried out for male or female aged between 18 and 60 with following conditions: 1. Persistent allergic rhinitis with moderate-to-severe or severe symptoms according to the guideline of Allergic Rhinitis and its Impact on Asthma (ARIA) initiative 2. Symptoms of chronic rhinosinusitis by ARIA guideline with the impression of maxillary sinusitis presented on Water's view X-ray
Key exclusion criteria	1. Serious medical conditions in cardiovascular, pulmonary gastrointestinal, genitourinary, neurologic and endocrine system all of which can affect acupuncture treatment 2. Acute/chronic respiratory infections that need systemic antibiotics or anti-tuberculosis agents within 14 days before enrolment 3. Anatomic malformation or history of nose surgery 4. Smoking over 9 cigarettes per day 5. Systemic corticosteroid administration within 6 months before enrolment 6. Any experience of acupuncture or herbal medicine for nasal symptoms within 6 months before enrolment
Date of first enrolment	09/03/2009
Date of final enrolment	30/04/2010

Locations

Countries of recruitment

Korea, South

Study participating centre

Korea Institute of Oriental Medicine

Daejeon
305-811
Korea, South

Sponsor information

Korea Institute of Oriental Medicine (South Korea)
Research organisation

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

Email	smchoi@kiom.re.kr
Website	http://www.kiom.re.kr
"ROR"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan