Introducing a preferred treatment method for treating facial muscle trigger points
Design
Experimental research (blind bilateral clinical trial)
Settings and conduct
Laser Department of Shahid Beheshti Dental School
Participants/Inclusion and exclusion criteria
Sample entry criteria:
1. Age over 18 years
2. The presence of a trigger point in the temporalis or master or external trigeminal muscles, which are identified by touch and examination.
Exclusion criteria:
1.Taking painkillers, muscle relaxants, anti-inflammatory drugs and benzodiazepines.
2.Tears, Cupping or laser
3. Bleeding disorders
4. Any underlying diseases such as metabolic (diabetes) and vascular
5. Neurological disorders (trigeminal neuralgia)
6. Pregnancy
7. Receive any treatment for temporomandibular joint disorder
Intervention groups
The first group will be treated with a low power laser of GA-AL-AS diode with a wavelength of 808 nm laser device
In the second group, treatment with dry needling (Tony brand) made in China with a gauge (0.18 * 13 mm) will be performed on the trigger points.
In the third group of Cupping patients, first the muscle trigger points in the master or temporalis or external trigeminal muscles are identified and the cupping is performed by an assistant from the oral diseases department under the supervision of a professor and specialist in pain and acupuncture.
Main outcome variables
Visual Analogue Scale VAS
Maximum mouth opening MMO
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N38
Registration date:2022-03-17, 1400/12/26
Registration timing:prospective
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Analgesic effect of 808nm low-level laser, dry needing and cupping in the treatment of MPDS
Public title
Comparing Analgesic effect of 808nm low-level laser, dry needing and cupping in the treatment of MPDS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
The presence of a trigger point in the temporalis or master or external trigeminal muscles that are identified by touch and examination
Exclusion criteria:
Taking painkillers, muscle relaxants, anti-inflammatory drugs and benzodiazepines
Fear of needles, cupping or lasers
Bleeding disorders
Any underlying diseases such as metabolic (diabetes) and vascular
Neurological disorders (trigeminal neuralgia)
Pregnancy
Receive any treatment for temporomandibular joint disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
single-digit random numbers were generated using Excel software. The order of these random numbers was considered as the number of people entering the study. If these numbers were between 1-3, the patient was assigned to the first group, between 4-6 to the second group, between 7-9 to the third group. Following the work of each group, to which 20 patients were assigned, the generated numbers related to that group were removed from the random number production chain.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical examination of all patients is performed by another specialized assistant of trained oral diseases under the supervision of neutral professors and the patients' details are recorded based on the information form. Relevant assistants and professors will not know that the patient belongs to the acupuncture and cupping group at any stage of the examination.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Biomedical Research of Shahid Beheshti University of medical sciences
Street address
Daneshjoo Blvd, Yaman street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.729
Health conditions studied
1
Description of health condition studied
myofascial trigger points pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Pain is recorded in the first session of the examination under VAS 1 and then in each treatment session at the beginning of the session before the start of the new treatment phase that day in the relevant schedule. The last amount of pain recording in the follow-up session is done 1 month after the completion of the treatment sessions as VAS 2 or Visit In 1 Month.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
(Maximum mouth opening)
Timepoint
In the first session, the examination is called MMO 1 and each session is recorded in the relevant table before starting the treatment. The last MMO registration in the follow-up session is done 1 month after the completion of the treatment sessions as MMO2 or Visit In 1 Mouth.
Method of measurement
By calibrated ruler in mm
Intervention groups
1
Description
Intervention group:The first group is treated with GA-AL-AS low power diode laser with a wavelength of 808 nm Konftec low power laser device made in Taiwan with a power of 250 ml watts for 60 seconds with a power of 15J and a density of 4 joules per square centimeter It is used at any point of the trigger as a Continuous Wave and the laser irradiation is done in contact with the gentle pressure of the device type with a Spot Size of 3 cubic centimeters in the irradiation area. First, the points of the muscle trigger are identified in the management of the master or temporalis or external trigoid, and then laser irradiation will be performed on the points. The number of treatment sessions will be 3 times a week, one day in between and a total of 8 sessions
Category
Treatment - Other
2
Description
Intervention group: In the second group, treatment with dry needling (Tony brand) made in China with a gauge (0.18 * 13 mm) will be performed on the trigger points. First we find the available trigger points and copy them with a pencil. To find trigger points, touch the muscle with medium to high pressure in all its parts. When the point of the muscle trigger was found, which was actually a relatively hard nodule to the touch, mark the skin of the trigger with a disinfected copy pencil, disinfect the skin with medical alcohol, and treat under the supervision of a professor. We start with a pain specialist and acupuncturist. Insertion of needle is gentle and 5 to 10 mm deep, uniform and intentional. If there is no reaction after the needle enters, the needle should stay in place for 2 to 3 minutes and then be removed.
Category
Treatment - Other
3
Description
Intervention group: In the third group of cupping patients, first the muscle trigger points in the master or temporalis or external trigeminal muscles are identified and cupping is performed by an assistant from the oral diseases department under the supervision of a professor and specialist in pain and acupuncture. Cupping does not have a lasting effect on the skin, it only causes temporary redness in some people. This treatment is vacuumed with a 10 cc disposable cup in the desired places with suction or vacuum hand tools to the extent that 1 cm of skin is highlighted under the vacuum inside the cup and stays on the place for 5 minutes with the same amount of negative pressure. It is repeated every other day
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Asnaashari
Street address
Velenjac Av. Teharn
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2271 8021
Email
mo_asana@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadi Banar
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.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
Dr Mohammad Asnaashari
Position
professor of shahid beheshti university of medical sciences
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, Velenjak
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2271 8021
Email
mo_asna12@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Asnaashari
Position
professor of shahid beheshti university of medical sciences
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, Velenjak
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2271 8021
Email
mo_asna12@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Asnaashari
Position
professor of shahid beheshti university of medical sciences
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2271 8021
Email
mo_asna12@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Dentists. Oral and maxillofacial surgeons
Under which criteria data/document could be used
Email the corresponding author and earn permission
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
Email the corresponding author, the authors' meeting, send the data at your discretion