Effectiveness of temporomandibular joint mobilization with & without neck strengthening exercises on patients with anterior disc displacement with reduction of temporomandibular joint
To evaluate the effectiveness of neck strengthening exercises on pain, Jaw mobility and clicking/popping sound of the disc displacement with reduction of temporomandibular joint in addition to routine physical therapy.
Design
Randomized controlled Clinical trial. A Superiority clinical trial. The treatments of interest have either superior effects or similar effects to the control group
Settings and conduct
study setting: University of Lahore Teaching Hospital, University of Lahore.
Study Duration: 9 Months after the approval of synopsis.
Non-probability; Purposive sampling technique.
It is a Single blinded study. The assessor and the data analyzer were blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
18-50 years
Male & Female
Temporomandibular joint Pain plus disc displacement with reduction.
4. Diagnosed Patients
Exclusion Criteria:
1. Recent tumor, fracture or trauma in recent medical history
2. Any Systemic/Rheumatic disease.
3. Degenerative changes seen
4. Surgical History of cervical spine Or Temporomandibular joint.
Intervention groups
For Control Group:
Manual Mobilization of Temporomandibular joint
Soft Tissue Release of Masticatory muscles
Therapeutic Exercises of Temporomandibular joint including Protrusion and Lateral shifting will be given for home plan.
For Treatment Group.
All of the above-mentioned treatment protocol with additionally strengthening exercises of deep neck flexors muscles including: Longus Capitus and Longus Colli muscles was given as a home plan thrice a day with 10 repetitions and 10 second hold
Main outcome variables
Pain intensity, Jaw Mobility, clicking sound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200823048495N2
Registration date:2021-02-12, 1399/11/24
Registration timing:retrospective
Last update:2021-02-12, 1399/11/24
Update count:0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
Umber Nawaz
Name of organization / entity
Knowledge Research and Innovation Center
Country
Pakistan
Phone
+92 42 35440889
Email address
umber@kric.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-06, 1398/12/16
Expected recruitment end date
2020-12-04, 1399/09/14
Actual recruitment start date
2019-12-04, 1398/09/13
Actual recruitment end date
2020-10-04, 1399/07/13
Trial completion date
2020-10-04, 1399/07/13
Scientific title
Effectiveness of temporomandibular joint mobilization with & without neck strengthening exercises on patients with anterior disc displacement with reduction of temporomandibular joint
Public title
Neck strengthening exercises in anterior disc displacement with reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Temporomandibular Joint Pain plus disc displacement with reduction
patient with a medical referral of Temporomandibular disorder by dentists/ maxillofacial surgeon
Symptoms for more than 1 month, at the time that the first treatment would be given
Exclusion criteria:
Recent tumor
fracture or trauma in recent medical history
Any Systemic/Rheumatic disease
Degenerative changes seen
Surgical History of cervical spine Or Temporomandibular joint
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
53
Actual sample size reached:
53
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Sealed Envelops
Odd number to the control group and Even number to the treatment group
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor have been blinded by simply not informing him of the group allocation of the participants. After Assessment the assessor was asked to handover the sealed envelope with a number written on the envelope. The Assessor was not aware of the random numbers and group allocation. Every odd number was then allocated to control group by the therapist and every even number was allocated to intervention group by the therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
World Health Organization Universal Trial Registry
Secondary trial Id
U1111-1262-8127
Registration date
2020-12-16, 1399/09/26
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of The University of Lahore, Faculty of Allied health Science,
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Approval date
2020-03-06, 1398/12/16
Ethics committee reference number
IRB-UOL-FAHS/718-XVI/2020
Health conditions studied
1
Description of health condition studied
Anterior disc displacement with reduction of Temporomandibular Joint Disorder
ICD-10 code
M26.63
ICD-10 code description
Articular disc disorder of temporomandibular joint
Primary outcomes
1
Description
Pain
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Numeric Pain Scale
2
Description
Jaw Mobility
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Measuring Scale
3
Description
Clicking Sounds
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Stethoscope
Secondary outcomes
1
Description
Helkimo Index
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Helkimo Index
Intervention groups
1
Description
Intervention group: Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid & Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold with additionally strengthening exercises of deep neck flexors muscles including: Longus Capitus and Longus Colli muscles was given as a home plan thrice a day with 10 repetitions and 10 second hold.
Category
Rehabilitation
2
Description
Control group: Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid & Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Lahore, Faculty of Allied health Science,
Full name of responsible person
Umber Nawaz
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Phone
+92 42 35321761
Email
info@uol.edu.pk
Web page address
https://www.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Phone
+92 42 35440889
Email
umber.nawaz@uipt.uol.edu.pk
Web page address
Grant name
Self
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
musculoskeletal Rehabilitation
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35321761
Email
umber.nawaz@uipt.uol.edu.pk
Web page address
https://www.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Musculoskeletal Manual Rehabilitation
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
0092 35440889
Email
umber@kric.edu.pk
Web page address
https://www.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Musculoskeletal Manual Rehabilitation
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35440889
Email
umber@kric.edu.pk
Web page address
https://www.uol.edu.pk
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcome measure
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Data will be available to all the researchers, academic institutions and common public.
Under which criteria data/document could be used
Data will be accessible to the researchers on request at umber@kric.edu.pk or umber.nawaz@uipt.uol.edu.pk
From where data/document is obtainable
communication and clear contact information such as email addresses mentioned previously along with cover letter and resume and purpose of the data need.
What processes are involved for a request to access data/document
Requested email to the following addresses: umber@kric.edu.pk, umber.nawaz@uipt.uol.edu.pk