The clinical trial to compare the effect of laser therapy associated with drug therapy on relieving the most common orofacial pains in patients who have trigeminel neuralgia, atypical facial pain and myofacial pain dysfunction syndrome
Objectives:
The purpose of this study is to evaluate the effect of low level diod(GA-AS) laser (850-980nm) with the frequency of 3000HZ and dose of 6.3 J/cm2 during 10 section of laser therapy on the orofacial pain of 60 patients.
Design:
This study is a randomized triple blind clinical trial with active (positive) concurrent control which is done on the phase of 2 of clinical trial.
Setting and conduct:
The patients in the group of case receive drug therapy in association with Low Level Laser therapy; however, the patients in the control group are treated with drug and sham laser. The patients and all of the operators of this study are not aware of the type of laser which is used for each patient.
Participants including major eligibility criteria:
The patients who have the criteria of Trigeminal Neuralgia, Atypical Facial Pain and Myofacial Pain Dysfunction Syndrome and the patients who have not a good response to routine drug therapy can enter the study; however, the patients who have a good response to previous drug therapy and the pregnant women are excluded.
Intervention:
In this study we evaluate the effect of low level diod(GA-AS) laser (850-980nm) with the frequency of 3000HZ and dose of 6.3 J/cm2 during 10 section of laser therapy on the orofacial pain of 60 patients.
Main outcome:
In order to evaluate the effect of laser therapy Visual Analogue Scale is used before and after intervention and in the period of 2 -4 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201018585N1
Registration date:2012-02-01, 1390/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2010-01-20, 1388/10/30
Expected recruitment end date
2012-02-29, 1390/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial to compare the effect of laser therapy associated with drug therapy on relieving the most common orofacial pains in patients who have trigeminel neuralgia, atypical facial pain and myofacial pain dysfunction syndrome
Public title
The effect of laser therapy on the orofacial pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having the criteria of each of the pains including Trigeminel Neuralgia, Atypical Facial Pain and Myofacial Pain Dysfunction Syndrome؛ The patients who have not a good response to routine drug therapy؛
Exclusion criteria: the patients who have a good response to previous drug therapy؛ The pregnant women
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Shiraz university of Medical Science
Street address
Zand street, Shiraz, Central building of Fars University of Medical Science
City
Shiraz
Postal code
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
CT-90-5886
Health conditions studied
1
Description of health condition studied
Trigeminal Neuralgia
ICD-10 code
G50.0
ICD-10 code description
Diseases of the nervous system,disorders of 5th cranial nerve
2
Description of health condition studied
Myofacial Pain Dysfunction Syndroms
ICD-10 code
M62.4
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue, Other disorders of muscle
3
Description of health condition studied
Atypical Facial Pain
ICD-10 code
G50.1
ICD-10 code description
Nerve, nerve root and plexus disorders, disorders of 5th cranial nerve
Primary outcomes
1
Description
The amount of pain
Timepoint
Before and after intervention and 2-4 months after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The metabolit of serotoninlike 5-hydroxy indole acetic acid (5-HIAA)
Timepoint
Before ,after,2-4 month after intervention
Method of measurement
24-hour urine
Intervention groups
1
Description
Intervention group:
10 section of Low level laser therapy (LLLT) + standard drug therapy of their pain
The type of laser is Ga-AS (Device model: DLT 101) with pulse mode-mod II of exposure.
The time of exposure is 5 min with frequency of 3000 HZ, 5 watt potency.The wave length of device is 980 -850 nm. According to these properties the total dose is 6.3 J/cm2.
The Laser is applied on the trigger point if it exists, if not the operator will choose some trigger points on the pathway of pain.
Category
Treatment - Other
2
Description
Control group:
Sham laser + Standard drug therapy of their pain
Diagnosis of orofacial pain:
Trigeminal neuralgia (TN) is the most common of the cranial neuralgias and chiefly affects individuals older than 50 years of age. It has characteristic clinical feature which include episode of intense shooting, stabbing pain that lasts for a few seconds and then completely disappear. The pain has electric like quality and is unilateral except in few cases.TN is precipitated by nonnoxious stimulation like a light touch on a trigger zone. Presence of trigger point is pathognomic for TN. The most common treatment recommended for TN is as followed:
Carabamazepin , Gabapentin, Lamotrigin, Phenitoein, Oxcarbazepin, Valproic acid , Topiramate
Other effective drugs other than anticonvulsants are Clonazepam , Baclofen, Diazepam, Pimozide
IHS system, use the term facial pain not fulfilling other criteria to describe patients with atypical facial pain. This pain is a chronic pain syndrome which does not fall into other diagnostic categories. The major manifestation of AFP is a constant dull, aching pain without an apparent cause. It’s not paroxysmal and doesn’t precipitate by activity and doesn’t follow any anatomic pattern. Analgesics have no effect on AFP but tricyclic antidepressants can reduce the pain. It seems that psycho therapy has an important role in AFP treatment.
Myofacial pain dysfunction syndrome (MPDS) is a muscular pain due to increased load and muscular hyperactivity. MPDS manifests as a dull pain with a tender trigger point in muscles, tendon and their fascias which are tender on palpation. The referral pain and autonomic symptoms can be detected on palpation of the trigger zone. The muscle relaxants (methocarbamol) and NSAIDs can relieve the symptoms.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School -Oral Medicine Department
Full name of responsible person
Dr. Fatemeh Lavaee
Street address
Ghasrdasht Street, Shiraz, Oral Medicine Department, Shiraz Dental School
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.Gholam Reza Hatam
Street address
Zand street, Shiraz,Central building of Fars University of Medical Science
City
Shiraz
Grant name
ردیف بودجه طرح های تحقیقاتی
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 Dental School
Full name of responsible person
Dr. Fatemeh Lavaee
Position
The assistant of oral medicine
Other areas of specialty/work
Street address
Ghasrdasht Street, Shiraz, Shiraz Dental School, Oral Medicine Department
City
Shiraz
Postal code
Phone
+98 71 1631 9309
Fax
Email
lavaeef@sums.ac.ir; fatemeh.lavaee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Dr. Fatemeh Lavaee
Position
The assistant of Oral Medicine
Other areas of specialty/work
Street address
Ghasrdasht Street, Shiraz, Shiraz Dental School, Oral Medicine Department
City
Shiraz
Postal code
Phone
+98 71 1631 9309
Fax
Email
lavaeef@sums.ac.ir; fatemeh.lavaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Dr. Fatemeh Lavaee
Position
The assistant of Oral Medicine
Other areas of specialty/work
Street address
Ghasrdasht Street, Shiraz, Shiraz Dental School, Oral Medicine Department
City
Shiraz
Postal code
Phone
+98 71 1631 9309
Fax
Email
lavaeef@sums.ac.ir; fatemeh.lavaee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)