Trigeminal neuralgia is a sudden pain radiating along the branch of the fifth nerve that usually appears unilaterally. It is the most painful part of many situations. A first step in pain control is drug therapy and carbamazepine is the standard drug for the treatment of pain. However, drug resistance during the treatment period, is leading to higher doses of medicine and surgery, which ultimately causes complications in both these cases. One of the new techniques for pain control is the use of laser therapy.
The aim of our study is to offer better , safer treatment and faster reduce pain ,with fewer side effects for patients with Trigeminal neuralgia (severe pain) .
In this randomized clinical trial (RCT) on 30 patients with trigeminal neuralgia that refer to neurology clinic of Imam Reza and the Oral medicine department of Shiraz university that will be treating with carbamazepin, are being conducted. Diagnosis of trigeminal neuralgia is confirmed by oral medicine specialist or neurologist . People with multiple sclerosis (MS) and has a history of herpes zoster (post herpetic neuralgia) are excluded. The general process for patients and their consent has been explained. Patients were randomly divided into two groups and control. VAS is taken from the patient before starting work. A gel layer contains a lot of water (no analgesic effect) on points for co2 laser is placed. Laser is emitted on the branches of the trigeminal nerve and TRIGGER point.for control group laser is off(sham). Immediatlly after laser therapy, one week, one month and three months later, VAS is taken from the patient. Patient and operator are using protective eyewear.
This variable is the degree of pain reduction.
General information
Acronym
NANTL
IRCT registration information
IRCT registration number:IRCT2013052113406N1
Registration date:2013-12-25, 1392/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Fahimeh Rezazadeh
Name of organization / entity
Dental school of shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 9917
Email address
rezazadehf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Scienses
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-05-19, 1393/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of non-ablative non-thermal co2 laser therapy(NANTL) on trigeminal neuralgia(double blind randomized clinical trial)
Public title
Evaluation of effect of non-ablative non-thermal laser therapy on trigeminal neuralgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: trigeminal neuralgia that use carbamazepin for treatment. Exclusion criteria: MS and postherpetic neuralgia.
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
CT-P-92-5731
Health conditions studied
1
Description of health condition studied
Trigeminal neuralgia
ICD-10 code
G50.0
ICD-10 code description
Trigeminal neuralgia
Primary outcomes
1
Description
Pain
Timepoint
Immediately after treatment, 2 weeks after and 1, 2, 6 months after
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
treatment with laser in intervention group
Category
Treatment - Other
2
Description
sham laser in control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral Medicine Department
Full name of responsible person
Street address
Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences
City
Sshiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Mosalanegad
Position
Student(under graduated)
Other areas of specialty/work
Street address
Dental School, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1634 7648
Fax
Email
mosalanegadf@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Dental School, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1634 7648
Fax
Email
rezazadehf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Dental School, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
Fax
Email
rezazadehf@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)