To compare the effect of cervical mobilization and thoracic manipulation on pain and function in myofascial temporomandibular joint dysfunction patients
Design
Randomized Clinical trial. (RCT)
Settings and conduct
• Life Line Hospital Lahore.
• Fatima Memorial Hospital Shadman Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 Myofascial pain in region of TMJ.
2. Reduced mouth opening measured by using 3fingers and 2 knuckles.
3. Age group in range of 20-40 years.
4. Females only.
5. Presence of any taut band and trigger point in surrounding area.
6. Reproduction of referred pain pattern of trigger point in response to palpation.
6.8 Exclusion criteria:
1. Degenerative TMJ arthritis
2. Malignant tumor of face and jaw.
3. History of fracture and dislocation of TMJ.
4. History of previous surgery of jaw or TMJ.
5. Neurological disorders includes stroke, bell’s palsy and spinal cord injury
6. Hypermobile TMJ.
7. Osteoporotic patient
Intervention groups
Group A : Cervical Mobilization
Group B : Thoracic Manipulation
Main outcome variables
1. Pain
2. Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191130045553N1
Registration date:2019-12-17, 1398/09/26
Registration timing:registered_while_recruiting
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Ayesha Mateen
Name of organization / entity
Riphah International University QIE Campus, Lahore.
Country
Pakistan
Phone
+92 42 35126110
Email address
ayeshamateen6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-02, 1398/09/11
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Cervical Mobilization and Thoracic Manipulation in Myofascial Temporomandibular Dysfunction to Improve Pain and Function
Public title
Comparison Of Cervical Mobilization and Thoracic Manipulation in Myofascial Temporomandibular Dysfunction to Improve Pain and Function.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1 Myofascial pain in region of TMJ.
Reduced mouth opening measured by using 3 fingers and 2 knuckles.
Age group in range of 20-40 years.
Females only.
Presence of any taut band and trigger point in surrounding area.
Reproduction of referred pain pattern of trigger point in response to palpation.
Exclusion criteria:
1. Degenerative TMJ arthritis.
Malignant tumor of face and jaw.
History of fracture and dislocation of TMJ.
History of previous surgery of jaw or TMJ.
Neurological disorders include stroke, bell's palsy and spinal cord injury.
Hypermobile TMJ.
Osteoporotic patient.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Once the above mentioned inclusion and exclusion criteria will be taken into account, potential participants will be considered. They will be requested to participate in the study. Written informed consent will be taken. Patient will be recruited into Group A and Group B by lottery method. Each participant will be requested to draw either odd number or even number from a box. Odd Numbers will be allocated to Group A and even number will be allocated to group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
single blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Riphah International University
Street address
13-14-C-Civic Center Near Hamdard Chowk ,Township ,Lahore.
City
Lahore
Postal code
54000
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
RCRS & AHS/REC/MS-OMPT/S19/001
Health conditions studied
1
Description of health condition studied
Temporomandibular Joint Dysfunction
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Pain
Timepoint
Treatment will be given to both group for 2 weeks,5 session per week
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Function
Timepoint
Treatment will be given to both group for 2 weeks,5 session per week
Method of measurement
Mandibular Function Impairment Questionnaire.(MFIQ)
3
Description
Function
Timepoint
Treatment will be given to both group for 2 weeks,5 session per week
Method of measurement
Temporomandibular Dysfunction Disability Index Questionnaire.(TMDIQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cervical Mobilzation
Category
Treatment - Other
2
Description
Intervention group: Thoracic Manipulation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Memorial Hospital Shadman, Lahore.
Full name of responsible person
Farhia Shah
Street address
Shadman Rd, Ichra Lahore,
City
Lahore
Postal code
54000
Phone
+92 42 35940444
Email
farhia@gmail.com
2
Recruitment center
Name of recruitment center
Life Line Hospital ,Lahore
Full name of responsible person
Muhammad Salman Bashir
Street address
462, 463 G3 Johar Town, Lahore,
City
Lahore
Postal code
54000
Phone
+92 42 35445684
Email
salman.bashir@riphah.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
13-14-C-Civic Center Near Hamdard Chowk, Township Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
salman.bashir@riphah.edu.pk
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
15
Public or private sector
Private
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
Riphah International University QIE Campus ,Lahore.
Full name of responsible person
Ayesha Mateen
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Center Near Hamdard Chowk,Township ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
ayeshamateen6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Center Near Hamdard Chowk,Township ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
salman.bashir@riphah.edu.pk.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Ayesha Mateen
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-Civic Center Near Hamdard Chowk,Township ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
ayeshamateen6@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
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
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