Comparative study of the effect of laser acupuncture and transcutaneous electrical nerve stimulation on pain reduction patients with myofascial pain dysfunction syndrome
Comparison of Needle Laser and physiotherapy Methods for Reducing Pain in Patients with Myofascial Pain Dysfunction Syndrome
Design
Clinical trials with two paralle groups, Non blind and randomized without placebo control
Settings and conduct
The project is conducted at the Department of Oral and Maxillofacial Diseases, College of Dentistry affiliated to Tehran University of Medical Sciences.
We divide the patients into two groups randomly.
The first group receives physiotherapy and the second group receives acupuncture laser.A total of 22 volunteers will participate in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 18-60 years old; pain in temporomandibular joint.
Non-Inclusion criteria: systemic articulo-muscular disorders
Intervention groups
Intervention group 1:Physiotherapy group in which 11 patients were treated with TENS device with 180 Hz frequency during 10 20-minute sessions .Intervention group 2: acupuncture group in which 11 patient were treated with diode laser with 940 nm and 0.5 w power.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090914002464N17
Registration date:2020-07-20, 1399/04/30
Registration timing:retrospective
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
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
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of laser acupuncture and transcutaneous electrical nerve stimulation on pain reduction patients with myofascial pain dysfunction syndrome
Public title
The effect of laser acupuncture and transcutaneous electrical nerve stimulation on pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participant between 18-60 years old
Patients With temporomandibular joint Disorder (TMJ) and pain equal or more than 4 according to visual analogue scale (VAS)
Exclusion criteria:
Systemic joint muscle disorder
Treated With Another Treatment
Pregnancy
History of Trauma to face
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
By table of random numbers
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, next to atomic energy institution, North Amirabad Avenue
City
Tehran
Province
Tehran
Postal code
1477935457
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.3872
Health conditions studied
1
Description of health condition studied
Tempolar-Mandibular joint Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tempolar mandibolar joint Pain
Timepoint
Measuring the pain at the beginning of the study (before the intervention) and twice a week for 5 weeks (totally ten sessions) and one month after the last session as follow up
Method of measurement
VAS Questionary
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: acupuncture group, Laser acupuncture is a method based on stimulating traditional acupuncture points with low power laser, in this group 11 patient were treated with diode laser with 940 nm (Epic, Biolase, USA) and 0.5 w for 40 seconds with continuous mode, tip diameter 5mm and cross section 0.19 cm2 in 3 acupuncture points of LI4, ST6, ST7 in each side.
Category
Treatment - Devices
2
Description
control group: Physiotherapy group with TENS for transcutaneous electrical nerve stimulation that 11 patients were treated with TENS (710 L) (Iran novin) device during 10 sessions for 20 min and 180 Hz frequently and Width 300 micro second.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Reyhane Palizgir
Street address
Tehran University of Medical Science, North Amirabad Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477935457
Phone
+98 21 5585 1151
Fax
+98 21 5585 1141
Email
p.reyhane@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reyhane Palizgir
Street address
Poursina street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
p.reyhane@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reyhane Palizgir
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 7, No 25, First East Ally, 24 Metri Blvd, Saadatabad
City
Tehran
Province
Tehran
Postal code
1997778863
Phone
+98 21 2235 0175
Email
p.reyhane@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shamsolmolouk Najafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 1, next to Sixth street, North Kargar street
City
Tehran
Province
Tehran
Postal code
1997778863
Phone
+98 21 8863 9818
Email
Najafi_sh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Palizgir Reyhane
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 7, No 25, First East Ally, 24 Metri Blvd, Saadatabad
City
Tehran
Province
Tehran
Postal code
1997778863
Phone
+98 21 2235 0175
Email
p.reyhane@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available