Trigeminal neuralgia (TN) is the most common neuralgia in the head and neck region and a common cause of orofacial pain. It is routinely treated with carbamazepine. Laser, acupuncture are among other treatment modalities for this condition.
This study sought to assess the efficacy of laser therapy in conjunction with carbamazepine for treatment of TN.
Method: Qualified individuals were classified in two groups, with double blind randomization method, one patient and other analyzer.
Inclusion criteria: Patients with definite diagnosis of TN according to the criteria of the International Headache Society (IHS) were included Patients who were under standard pharmaceutical treatment for TN but had not experienced any improvement were also included.
Exclusion criteria: pregnancy Patients.
All patients received 100mg carbamazepine at baseline and another 100mg after two days for pain control. In the case group, low level laser therapy (LLLT) was also performed in addition to pharmaceutical therapy. Sham laser was used in the control group instead of LLLT. Treatment was continued for 10 sessions (3 days a week).
The main consequence is a reduction in pain intensity and effectiveness of the laser.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601142464N15
Registration date:2016-12-23, 1395/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Shamsolmolok Najafi
Name of organization / entity
Faculty od Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 0375
Email address
najafi_sh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic and analgesic efficacy of laser in conjunction with pharmaceutical therapy for trigeminal neuralgia
Public title
Therapeutic and analgesic efficacy of laser in conjunction with pharmaceutical therapy for trigeminal neuralgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with definite diagnosis of TN according to the criteria of the International Headache Society (IHS) were included [HIS 3 with ICD-10 (G44.0) coding]; Patients who were under standard pharmaceutical treatment for TN but had not experienced any improvement were also included.
Exclusion criteria: pregnancy Patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Tehran University of Medical Sciences / School of Dentistry, Tehran Universi
Street address
Shariati 3 Way Mahan, Khani Abad neo-Ave, Tehran, School of Dentistry, Tehran University of Medical Sciences International Campus, Tehran
City
Tehran
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.TUMS.VCR.REC.1395.498
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
Compare the severity of pain
Timepoint
Before treatment - Upon completion of treatment- At two months after completion of treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
The side effects of the drug include dizziness
Timepoint
Before treatment- Upon completion of treatment-At two months after completion of treatment
Method of measurement
According patient
Intervention groups
1
Description
Intervention Group:
Laser treatment with medication
Medication: Tablets 200 mg orally, once a day for three months
Laser:
GaAlAS diode laser with a wavelength of 810 nm, continus form, dose 6.36 J/cm for over ten treatment sessions 3 times a week.
Time laser irradiation for 25 seconds and a maximum power of 200 mW.
Category
Treatment - Drugs
2
Description
Control group:
Medication with sham laser
Medication: Carbamazepine, tablets, 200 mg orally, once a day for three months
Laser: Sham laser
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences / School of Dentistry, Tehran University of Medical Sciences I
Full name of responsible person
Street address
Shariati 3 Way Mahan, Khani Abad neo-Ave, Tehran, School of Dentistry, Tehran University of Medical Sciences International Campus, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr Abbas Akhondi
Street address
Ghods streets, Enghelab ave, Faculty of Dentistry, Dental Research Center, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences / School of Dentistry, Tehran University of Medical Sciences I
Full name of responsible person
Dr. Shamsoulmolouk Najafi
Position
Faculty and Assistant Professor
Other areas of specialty/work
Street address
Shariati 3 Way Mahan, Khani Abad neo-Ave, Tehran, School of Dentistry, Tehran University of Medical Sciences International Campus, Tehran
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
najafi_drsh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences / School of Dentistry, Tehran University of Medical Sciences I
Full name of responsible person
Dr. Shamsoulmolouk Najafi
Position
Faculty and Assistant Professor
Other areas of specialty/work
Street address
Shariati 3 Way Mahan, Khani Abad neo-Ave, Tehran, School of Dentistry, Tehran University of Medical Sciences International Campus, Tehran
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
najafi_drsh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences / School of Dentistry, Tehran University of Medical Sciences I
Full name of responsible person
Dr. Shamsoulmolouk Najafi
Position
Faculty and Assistant Professor
Other areas of specialty/work
Street address
Shariati 3 Way Mahan, Khani Abad neo-Ave, Tehran, School of Dentistry, Tehran University of Medical Sciences International Campus, Tehran
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
najafi_drsh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)