Comparative evaluation of Low level laser therapy and Trans Epidermal Nerve stimulation as adjuvant therapies to drug therapy in Myofascial pain dysfunction syndrome
Objectives: Determination the amount of pain changes with low level laser therapy and trens epidermal nerve stimulation in patients with myofacial pain dysfunction syndrome.
Design: This study is a Randomized clinical trial. The study population is reffered patients with myofacial pain dysfunction syndrom to the department of oral and maxillofacial medicine, Dental faculty, Tehran university of medical sciences that are divided in to three groups including Laser therapy, Trans epidermal nerve stimulation and Drug therapy only, via block randomization.
Setting and conduct: 10 sessions of Laser therapy twice a week, 10 sessions of TENS three times a week, drug therapy for 2 months. All the groups will receive the drugs.
Participants:
Inclusion criteria: Pain and tenderness of masticatory muscles.
Exclusion criteria: Tempromandibular joint disorders with articular origin according to Research and Diagnostic Criteria for Tempromandibular Joint Disorders( RDC/TMD) ;Osteoartherities or hernia of the disc of neck vertebra;History of trauma; Removable prosthesis or missing of more than one tooth in each quadrant; Major malocclusion (anterior openbite, maxillary unilateral lingual crossbite, overjet > 6mm).
Interventions: drug therapy in control and intervention groups, low level laser therapy in one intervention group, trans epidermal nerve stimulation(TENS) in the other intervention group.
Main outcome measures: primary outcome measure is pain reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411113144N4
Registration date:2015-09-05, 1394/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Arash Mansourian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 1833 8400
Email address
amansourian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of Low level laser therapy and Trans Epidermal Nerve stimulation as adjuvant therapies to drug therapy in Myofascial pain dysfunction syndrome
Public title
The effect of Laser and Trans Epidermal Nerve Stimulation on Myofascial Pain Dysfunction Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-60 years; Pain and tenderness of masticatory muscles with or without limitation of range of motion, click in tempromandibular joint, deviation and deflection of mandible in opening; normal posterior occlusion; Orofacial pain existing at least for 6 months.
Exclusion criteria: Tempromandibular joint disorders with articular origin according to RDC/TMD criteria; Systemic diseases including cardiovascular, infectious, inflammatory ,psychological diseases , seizures and tumors which can have effect on clinical appearance of the disease; Osteoartherities or hernia of the disc of neck vertebra; History of trauma; Removable prosthesis or missing of more than one tooth in each quadrant; Major malocclusion (anterior openbite, maxillary unilateral lingual crossbite, overjet > 6mm).
Age
From 32 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization is used in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical Science
Street address
Vice chancellor for research of Tehran University of Medical Sciences, number 23, Dameshcue street, Palestin street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
142107
Health conditions studied
1
Description of health condition studied
Myofascial pain dysfunction syndrome
ICD-10 code
M60, M61,
ICD-10 code description
Disorders of muscles
Primary outcomes
1
Description
pain
Timepoint
before treatment, after each treatment session, after the end of treatment weekly up to 2 months
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Fluoxetin 10 mg(Tehran Daroo), once a day
Tablet Clonazepam 0.25 mg(Sobhan Daroo), once a day
Tablet Baclofen(Zahravi) 10 mg, three times a day
Category
Treatment - Drugs
2
Description
low level laser therapy( Ga-Al-Arsen,countinus wave, λ=660 nm, p=200 mW, t=10 s )10 sessions, 2 times a week
Category
Rehabilitation
3
Description
Trans epidermal nerve stimulation (TENS) (NEWTENS 900F, Novin medical Engineering, P= 20w, Voltage=220v, Freq=50Hz) 10 session, 3 times a week
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of oral and maxillofacial medicine, Dental faculty of Tehran university of medical scienc
Full name of responsible person
Maryam Sadat Sadrzadeh Afshar
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Mohammad sadegh Akhoondi
Street address
Research Center of Dental sciences, NO 20, Ghods street, Enghelab street.
City
Tehran
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 of 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
Dental faculty, Tehran University of Medical Sciences
Full name of responsible person
Maryam Sadat Sadrzadeh Afshar
Position
post graduate student of oral and maxillofacial medicine
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1152
Fax
+98 21 6640 1132
Email
m_sadrzade@razi.tums.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Tehran University of Medical Sciences
Full name of responsible person
Arash Mansourian
Position
Oral and maxillofacial medicine Board
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 8801 5800
Fax
+98 21 6640 1132
Email
amansourian@tums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty, Tehran University of Medical Sciences
Full name of responsible person
Sara Pourshahidi
Position
Oral & Maxillofacial Medicine board
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 22183384000
Fax
+98 21 6640 1132
Email
sarapourshahidi20@hotmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)