Comparison of the effect of 808 nm low-power laser and dry needling on treatment of trigger points in patients with myofascial pain syndrome (MPDS)
Design
A clinical trial has two groups of treatment with parallel randomized groups
Settings and conduct
A total of 42 who are having Myofascial Pain Syndrome(MPDS) and who have criteria for entering the study are selected.A clinical examination is conducted by a specialist assistant in oral diseases under the supervision of Professor of Oral Medicine. The pain status at the patient's trigger points is recorded based on the VAS criteria in the initial examination, called VAS1.Patients are randomly divided into two groups of 21 patients. In the two treatment groups, muscle trigger points are used, which requires finding trigger points in the muscles.Muscles that are commonly used in trigger therapy include temporalis,mast, and external trigoid.Low-power laser GA-AL-AS lasers with a wavelength of 808 nm and a power of 0.5 watts for 60 seconds, with a power of 30 J at any point of the trigger and in the form of a continuous wave.In the other group, treatment is performed by dry needle in muscle trigger points.
Participants/Inclusion and exclusion criteria
Entry requirements:
Age over 18 years
The presence of a trigger point in the temporal muscle and / or the external master and / or trigoid that has been previously indicated by touch
Non-arrival conditions:
Use of analgesics, muscle relaxants, anti-inflammatory drugs and benzodiazepines
Needle Foobia Hemorrhagic disordersMetabolic diseases (diabetes) and vascular. Neurological disorders (Trigeminal neuralgia)- Pregnancy. Receiving any treatment for temporomandibular joint disorder
Intervention groups
Trigger point therapy of by low level laser 808 nmand dry needling
Main outcome variables
Reducing pain in the muscle trigger points
Reduce the number of muscle trigger points
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190523043679N1
Registration date:2019-08-19, 1398/05/28
Registration timing:retrospective
Last update:2019-08-19, 1398/05/28
Update count:0
Registration date
2019-08-19, 1398/05/28
Registrant information
Name
Azin Khodabakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4604 3561
Email address
azinkhodabakhshi1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of 808nm low-level laser and dry needling in the treatment of trigger point in patients with MPDS
Public title
Treating muscle pain by low-power laser and dry needle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
The presence of a trigger point in the temporal muscle and / or the external master and / or trigoid that has already been marked with a touch
Exclusion criteria:
Use of analgesics, muscle relaxants, anti-inflammatory drugs and benzodiazepines
Fear of the needle
Bleeding disorders
Metabolic (diabetes) and vascular diseases
Neurological disorders (trigeminal neuralgia).
Pregnancy
Get any treatment for temporomandibular joint disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Not 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
National Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Sardar St. South Jungle End of Sadra
City
Tehran
Province
Tehran
Postal code
6581864858
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.SBMU.DRC.REC.1397.046
Health conditions studied
1
Description of health condition studied
Myofascial pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain in the triage of the masticatory muscles
Timepoint
Before and after each treatment and after ten days and one month
Method of measurement
by VAS
2
Description
Maximum opening of the mouth without pain
Timepoint
Before and after each treatment and after ten days and one month
Method of measurement
By the ruler, the distance between the anisal edges of the anterior teeth is measured
3
Description
Number of muscle trigger points
Timepoint
Before and after each treatment and after ten days and one month
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment of muscle trigger points by low-power laser 808 nm
Category
Treatment - Devices
2
Description
Intervention group: Treating muscle trigger points by dry needling
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Shaheed Beheshti Department of Oral and Maxillofacial Medicine
Full name of responsible person
Maryam Baharvand
Street address
Evin Blvd Student, Shahid Beheshti Dental School
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
M.baharvand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Evin, Blvd Student
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
M.baharvand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Baharvand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Evin, Student Blvd.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
M.Baharvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Baharvand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Evin, Student Blvd, Shahid Beheshti Dental School
City
Tehran
Province
Tehran
Postal code
1983967411
Phone
+98 21 2217 5350
Email
M.baharvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azin Khodabakhshi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Evin, Student Blvd, Shahid Beheshti Dental School
City
Tehran
Province
Tehran
Postal code
1983967411
Phone
+98 21 2217 5350
Email
Azinkhodabakhshi1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data and study data may be published
When the data will become available and for how long
Starting the access period from 2019
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Researchers working in academia and academia
From where data/document is obtainable
Researchers working in academia and academics will email the person in charge and request information.
What processes are involved for a request to access data/document
Researchers working in academia and academics will email the person in charge and request information.