Purpose: The comparison of therapeutic effect of carbamazepin and combination therapy with gabapentin and baclofen in trigeminal neuralgia
Main inclusion criteria: Patients with trigeminal neuralgia
Main exclusion criteria: Patients with trigeminal neuralgia and other systemic diseases
Study group: Patients with trigeminal neuralgia referred to yazd dental school
Sample size: 40 people
Study intervention: Carbamazepin 200 milligram 3 times daily, Gabapentin 100 milligram and Baclofen 10 milligram 3 times daily
Timing: 4 months
Primary outcome measure: clinical functional score, pain intensity changes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202219103N1
Registration date:2012-03-25, 1391/01/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-25, 1391/01/06
Registrant information
Name
Neda Gholami
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 35 1622 0022
Email address
drahadian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Science
Expected recruitment start date
2012-01-10, 1390/10/20
Expected recruitment end date
2012-01-30, 1390/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The camparison of therapeutic effect of carbamazepine and combination therapy with gabapentin and baclofen, in the treatment of trigeminal neuralgia.
Public title
Carbamazepine effect in trigeminal neuragia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with trigeminal neuralgia
Exclusion criteria: Patients with trigeminal neuralgia and other systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadoughi University of Medical Science
Street address
Central part of the Shahid Sadoughi University of Medical Science, Shahid Bahounar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2012-01-04, 1390/10/14
Ethics committee reference number
171126895
Health conditions studied
1
Description of health condition studied
trigeminal neuralgia
ICD-10 code
G50.0
ICD-10 code description
Syndrome of paroxysmal facial pain Tic douloureux
Primary outcomes
1
Description
clinical functional score
Timepoint
1 week, 3 weak, 2 mounth, 3 mounth, 4 mounth
Method of measurement
1) same pain 2) tingling and shocking pain 3)tingling 4)complete resolve
2
Description
pain intensity changes
Timepoint
1 week, 3 weak, 2 mounth, 3 mounth, 4 mounth
Method of measurement
vas
Secondary outcomes
1
Description
drug side effects
Timepoint
3 weeks
Method of measurement
Laboratory tests
Intervention groups
1
Description
200 mg carbamazepine/oral/ 3 times daily / 4 mounths