Condition category
Ear, Nose and Throat
Date applied
06/03/2009
Date assigned
16/03/2009
Last edited
01/04/2010
Prospective/Retrospective
Retrospectively 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 Jung Won Kang

ORCID ID

Contact details

Korea Institute of Oriental Medicine
483 Exporo Yuseong-gu
Daejeon
305-811
Korea
South
drkang@kiom.re.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KI0901

Study information

Scientific title

Acupuncture for treating Persistent Allergic Rhinitis with comorbid Chronic Maxillary Sinusitis: a randomised sham-controlled pilot trial

Acronym

Acupuncture for PER with CMS

Study hypothesis

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

Daegeon Oriental Hospital Ethics Committee, approved on 23/01/2009.

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

09/03/2009

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

09/03/2009

Recruitment end date

30/04/2010

Locations

Countries of recruitment

Korea, South

Trial participating centre

Korea Institute of Oriental Medicine
Daejeon
305-811
Korea, South

Sponsor information

Organisation

Korea Institute of Oriental Medicine (South Korea)

Sponsor details

483 Exporo Yuseong-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

Publication citations

Additional files

Editorial Notes