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Trial registered on ANZCTR


Registration number
ACTRN12608000560392
Ethics application status
Approved
Date submitted
30/08/2008
Date registered
7/11/2008
Date last updated
7/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
effect of turbinoplasty in concha bullosa induced rhinogenic headaches
Scientific title
effects of turbinoplasty on the headaches of patients with concha bullosa induced rhinogenic headaches in comparison with medical treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concha bullosa induced rhinogenic headaches 3626 0
concha bullosa induced rhinogenic headaches 3732 0
Condition category
Condition code
Anaesthesiology 3788 3788 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
nasal surgery :turbinoplasty
patients sedated with phentanyl 1.5 microgram/kg and midazolam 50 microgram/kg then with nasal endoscopy a sagital incision is made along anterior face of middle turbinate then straight forceps are used to remove the contents within the middle turbinate including internal mucosa.in the next step lateral and medial surfaces of middle concha approximate together so in addition to releive contact points,the middle concha becomes smaller.this is a simple endoscopic procedure estimated one hour to complete.
Intervention code [1] 3337 0
Treatment: Surgery
Comparator / control treatment
medical treatment with drugs:
fluticazone nasal spray(50mg,50microgm/puff) 2 puffs every 24 hours
pseudoephedrine tablet 30mg every 8 hours
both for 1.5 months
Control group
Active

Outcomes
Primary outcome [1] 4685 0
headaches severity measured by visual analoge score (VAS)
Timepoint [1] 4685 0
0,1.5, 3, 6 months
Secondary outcome [1] 7901 0
headaches duration measured by questionnaire as length of each headache in hours per attack
Timepoint [1] 7901 0
0,1.5,3,6 months

Eligibility
Key inclusion criteria
normal ophtalmologic,neurologic physical exam
no history of ophtalmologic and neurologic disease
no sinus disease in examination and x-ray and computerized tumography (CT)-Scan imaging
relieving of pain 5 minutes after application of anesthetics on contact points
Minimum age
25 Years
Maximum age
57 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known sinus,opthalmologic ,neurological disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1174 0
Iran, Islamic Republic Of
State/province [1] 1174 0

Funding & Sponsors
Funding source category [1] 3937 0
Self funded/Unfunded
Name [1] 3937 0
mohammad ebrahim yarmohammadi
Address [1] 3937 0
mostafa khomeini hospital
italia street
Tehran,Iran
postcode : 14166
Country [1] 3937 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
mohammad ebrahim yarmohammadi
Address
mostafa khomeini hospital
italia street
Tehran,Iran
postcode : 14166
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3531 0
None
Name [1] 3531 0
Address [1] 3531 0
Country [1] 3531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6002 0
ethics commitee of shahed university faculty of medicine
Ethics committee address [1] 6002 0
shahed faculty of medicine
dehkadeh st.
keshavarz blvd.
tehran,Iran
postcode: 14166
Ethics committee country [1] 6002 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6002 0
Approval date [1] 6002 0
01/11/2001
Ethics approval number [1] 6002 0

Summary
Brief summary
Headaches is extremely common and the etiologic factors are quite varied. Rhinogenic headache has recognized for many years. Contact points headaches are one of the subgroups of rhinogenic headaches. Any pneumatization of the hanging portion of the middle turbinate is classified as concha bullosa and has seen in 34% of patients with sinusitis and 15.9% of normal people. Prevalence of bilateral middle turbinate bullosa is reported in 16_45% of people. Middle turbinate bullosa can contact to the septum or the lateral nasal wall in the osteomeatal complex region so it may cause rhinogenic headache. This study has done to evaluate the efficacy of turbinoplasty in the treatment of rhinogenic headaches which caused by concha bullosa of middle turbinate.
The study was conducted between the years 2001 to 2006 on 44 patients with periorbital or frontal headaches caused by concha bullosa who divided into two equal groups at random. One group was treated by surgical therapy and other group was treated by medical therapy and efficacy of two methods compared by visual analog scale in 1.5,3,6 months after operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28887 0
Address 28887 0
Country 28887 0
Phone 28887 0
Fax 28887 0
Email 28887 0
Contact person for public queries
Name 12044 0
shahryar pourfarzam
Address 12044 0
mostafa khomeini hospital
italia street
Tehran,Iran
postcode:14166
Country 12044 0
Iran, Islamic Republic Of
Phone 12044 0
+982188963122
Fax 12044 0
+982188963122
Email 12044 0
poorfarzam@shahed.ac.ir
Contact person for scientific queries
Name 2972 0
mohammad ebrahim yarmohammadi
Address 2972 0
mostafa khomeini hospital
italia street
Tehran,Iran
post code 14166
Country 2972 0
Iran, Islamic Republic Of
Phone 2972 0
+982188963122
Fax 2972 0
+982188963122
Email 2972 0
meyarmohamadi@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary