Comparative evaluation of treatment effect on patients with
Myofacial Pain Dysfunction Syndrome (MPDS) by low level laser therapy and Transcutaneous Electrical Nerve stimulation (TENS)
The purpose of this randomized clinical trial study is the effect of two different treatment modalities on patients who referred to tempromandibular dysfunction (TMD) department of dental school of Tehran university of medical sciences. Patients with inability of mouth opening, pain history in masster, lateral, internal petrygoid, pain history in mouth opening and closing which diagnosed by oral and maxiofacial surgeon are selected for this study. After signing the informed consent, the demographic information of patients is recorded. The patients are randomly divided to 2 groups of laser and physiotherapy. In first group, patients are treated with Transcutaneous Electrical Nerve Stimulation (TENS) 3 times a week for 10 sessions and second group with low level laser with wavelength of 810 nm in continuous mode for 10 sessions. The energy of laser for each trigger point is 2 J. the data from Questionnaire are analyzed to evaluate the satisfaction level of each treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209087680N2
Registration date:2012-10-11, 1391/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-11, 1391/07/20
Registrant information
Name
Nasim Chiniforush
Name of organization / entity
Laser Research Center of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 7429
Email address
n-chiniforush@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser research center of dentistry
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-10-07, 1392/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of treatment effect on patients with
Myofacial Pain Dysfunction Syndrome (MPDS) by low level laser therapy and Transcutaneous Electrical Nerve stimulation (TENS)
Public title
The effect of low level laser and physiotherapy on patients with muscle spasms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: inability of mouth opening, pain history in masster, lateral, internal petrygoid, pain history in mouth opening and closing, headache and neckache, clicking. Exclusion criteria: pregnancy and history of cancer.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical sciences, Gouds Avenue
City
Tehran
Postal code
Approval date
2012-09-05, 1391/06/15
Ethics committee reference number
63873
Health conditions studied
1
Description of health condition studied
joint-pain syndrome
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint-pain-dysfunction syndrome
Primary outcomes
1
Description
Muscle stiffness
Timepoint
one week later, one month later, three month later
Method of measurement
VAS
2
Description
stress
Timepoint
one week later, one month later, three month later
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: laser irradiation with 2J energy three times a week for 10 sessions
Category
Rehabilitation
2
Description
TENS(transcutaneous electrical nerve stimulation) for 10 sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
TMJ department, School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Laser Research Center of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Abbas Monzavi
Street address
Qouds avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser Research Center of Dentistry, 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
Laser Research Center of Dentistry
Full name of responsible person
Nasim Chiniforush
Position
Research supervisor
Other areas of specialty/work
Street address
School of dentistry, Tehran University of Medical sciences, North Amirabad
City
Tehran
Postal code
Phone
+98 21 8801 5017
Fax
Email
n-chiniforush@farabi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser Research Center of Dentistry
Full name of responsible person
Reza Fekrazad
Position
MS, DDS
Other areas of specialty/work
Street address
Schoo of dentistry, Tehran University of Medical Sciences, North Amirabad
City
Tehran
Postal code
Phone
+98 21 8801 5017
Fax
Email
dr_rfekrazad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Nasim Chiniforush
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
n-chiniforush@farabi.tums.ac.i
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)