Comparison of the effect of Meloxib with physical therapy (TENS & infrared) on improvement of TMD symptoms in the referrals to Qom medical clinics in 2018-2019
Comparative effect of the Meloxib and physical therapy(TENS & infrared) on improvement of TMD symptoms in the Referrals to Qom medical clinics in 2018-2019
Design
The clinical trial has two treatment groups with parallel, non-blinded and randomized groups, phase 3, 46 patients
Settings and conduct
Patients referring to Qom Medical Sciences Clinics were selected according to the inclusion and exclusion criteria. Research process were explained to them and then randomly assigned to one of two treatment groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a history of TMD include women and men aged 15-60 years.
Exclusion criteria: Includes history of arthritis and other systemic joint diseases and articular dislocation.
Intervention groups
There were two treatment groups in this study, in the physiotherapy group patients underwent tens & infrared therapy, and in the drug group, patients used meloxib pills
Comparison of the effect of Meloxib with physical therapy (TENS & infrared) on improvement of TMD symptoms in the referrals to Qom medical clinics in 2018-2019
Public title
effect of meloxib & physiotherapy in TMD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of myofacial pain of TMD
Both sexes
Aged 15-60 years
Exclusion criteria:
Arthritis and other systemic joint diseases
Articular dislocation
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, all patients referred to the clinic because of musculoskeletal pain due to temporomandibular disease, divided to two groups randomly by drawing.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Shahid Lavasani St, University of Dentistry of Qom
City
Qom
Province
Ghoum
Postal code
3713649367
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.MUQ.REC.1397.124
Health conditions studied
1
Description of health condition studied
temporomandibulr disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
masticatory muscles tenderness
Timepoint
First and last day (30) of study
Method of measurement
questionnaire and examination
2
Description
joint sounds
Timepoint
first and last day of study
Method of measurement
questionnaire and examination
3
Description
mouth opening limitation
Timepoint
first and last day of study
Method of measurement
questionnaire and examination
4
Description
subluxation
Timepoint
first and last day of study
Method of measurement
questionnaire and examination
5
Description
deviation
Timepoint
first and last day of study
Method of measurement
questionnaire and examination
6
Description
limitation on lateral movement
Timepoint
first and last day of study
Method of measurement
questionnaire and examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: tab meloxibe 7.5 mg , for 30 days, once a day
Category
Treatment - Drugs
2
Description
Intervention group 2: physiotherapy (tens & infrared), 10 session, 3 times in week for 4 week, 20 minutes infrared and 5 minutes tens each session
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom medical science hospital
Full name of responsible person
Melika Sharifi
Street address
Qom, Lavasani St, university of dentistry of Qom
City
Qom
Province
Ghoum
Postal code
9367371364
Phone
+98 25 3770 0094
Email
ml_sharifi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Mehdizadeh
Street address
Qom. Lavasani St .Dentistry University
City
Qom
Province
Ghoum
Postal code
3713649369
Phone
+98 25 3770 0094
Email
Mehdizadehmo19@gmail .com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
10
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
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Mehdizadh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom, Lavasani St, University of Dentistry of Qom
City
Qom
Province
Ghoum
Postal code
3713649367
Phone
+98 25 3770 0094
Email
Mehdizadehmo19@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Mehdizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom, Lavasani St ,University of Dentistry of Qom
City
Qom
Province
Ghoum
Postal code
3713649367
Phone
+98 25 3770 0094
Email
Mehdizadehmo19@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Mehdizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qom, Lavasani St , University of Dentistry of Qom
City
Qom
Province
Ghoum
Postal code
3713649367
Phone
+98 25 3770 0094
Email
mehdizadehmo19@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