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Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.

Protocol summary

Study aim
To compare the effects of Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.
Design
Parallel group, single-blinded, randomized controlled trial
Settings and conduct
OPD Physiotherapy department university of Lahore, Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:- age of 18-55 years old, and with primary complaints of NSNP (symptoms lasting for at least 3 months), one of the four signs of TMD (joint sounds, deviation during mouth opening, muscle pain at a minimum of two tender points in the temporalis or masseter muscles and pain during mouth opening), Both male and female patients, Exclusion Criteria:- acute muscle trauma, received physiotherapy during the previous 3 months, unilateral and bilateral upper extremity symptoms, any neurological disorders, Musculoskeletal systemic disease, serious spinal pathology.
Intervention groups
All person who came to physiotherapy department OPD, university of Lahore was consider and assess for NSNP. 50 patients were randomly apportioned into 2 groups, 25 patients in each group. Gathering A patient were dealt with routine physiotherapy while Group B patients were treated with jaw activities and routine physiotherapy. Randomization of patients into groups were finished by mean of lottery strategy. Plan of the investigation was single blinded RCT. In which patients was kept blind. Furthermore, in this investigation patients were kept visor.
Main outcome variables
• Pain, ROM, Functional Activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200611047734N3
Registration date: 2021-09-19, 1400/06/28
Registration timing: retrospective

Last update: 2021-09-19, 1400/06/28
Update count: 0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
AYESHA RAZZAQ
Name of organization / entity
King Edward Medical University,Lahore
Country
Pakistan
Phone
+92 61 6521475
Email address
drayesharazzak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-02, 1398/10/12
Expected recruitment end date
2020-10-02, 1399/07/11
Actual recruitment start date
2020-03-07, 1398/12/17
Actual recruitment end date
2020-12-07, 1399/09/17
Trial completion date
2020-12-07, 1399/09/17
Scientific title
Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.
Public title
Effects of TMJ exercises on pain, range of motion and functional disability in patient with non-specific neck pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-55 years old With primary complaints of NSNP (symptoms lasting for at least 3 months) One of the four signs of TMD (joint sounds, deviation during mouth opening, muscle pain at a minimum of two tender points in the temporalis or masseter muscles and pain during mouth opening). Both male and female patients The severity of pain should be adequate (on a numerical pain rating scale it should be higher than 2 out of 10) for approving a clinically beneficial effect to be exhibited
Exclusion criteria:
Acute muscle trauma, Received physiotherapy during the previous 3 months Unilateral and bilateral upper extremity symptoms Any neurological disorders. Musculoskeletal systemic disease Serious spinal pathology Thoracic outlet syndrome Cervical rib Cervicogenic headache and vertigo. The previous history of whiplash trauma, prior to 6 weeks of inspection .Patients with h/o fractures of cervical or thoracic spine Any former h/o cervico-thoracic surgery
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
25 patients will be in each group, estimated by using 5% level of significance, 90% power of test
Actual sample size reached: 50
More than 1 sample in each individual
Actual sample size in each individual: 2
25 patients will be in each group, estimated by using 5% level of significance, 90% power of test
Randomization (investigator's opinion)
Randomized
Randomization description
All the participants who will come to the physiotherapy department will be considered and screen for nonspecific neck pain. 50 patients will be allotted in two groups i.e.; group A(routine physiotherapy) and group B(TMJ exercise+ routine physiotherapy) via lottery method, 25 in each group. patients with having lottery number with group A treated with just baseline treatment of physiotherapy, and patient having lottery method with Group B managed with baseline treatment and also receive a additional technique that was TMJ exercise.
Blinding (investigator's opinion)
Single blinded
Blinding description
it will be a single-blind study in which participant/ patients will be kept blind for treatment technique. 2 different technique will be provided to patients. and they will blind about that which technique will be given to which patients.
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board
Street address
Raiwind road lahore
City
LAHORE
Postal code
55150
Approval date
2020-03-06, 1398/12/16
Ethics committee reference number
IRB UOL FAHS/734 111/2020

Health conditions studied

1

Description of health condition studied
nonspecific neck pain
ICD-10 code
M43.02
ICD-10 code description
Spondylolysis, cervical region

Primary outcomes

1

Description
Pain
Timepoint
Baseline and after 4th week
Method of measurement
Numeriac pain rating scale

2

Description
Range of motion
Timepoint
Baseline and after 4th week
Method of measurement
Goniometer

3

Description
Functional activity
Timepoint
Baseline and after 4th week
Method of measurement
Neck Functional Disability index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A (Routine Physiotherapy): - Hot pack + TENS+ neck isometrics exercises. Dosage: - o Hot pack for 20 minutes o TENS= 100Hz, 50 µ s pulse, 20 minutes.o Isometrics Neck exercise = 10 times repetition .
Category
Treatment - Devices

2

Description
Intervention group: Group B (Jaw Exercises + Routine Physiotherapy): - Hot pack + TENS+ jaw exercises + neck isometrics exercises. Dosage: - o Hot pack for 20 minutes o TENS= 100Hz, 50 µ s pulse, 20 minutes.o Jaw exercises: - 10 times repetitiono Isometrics Neck exercise = 10 times repetition .
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
OPD Physiotherapy department university of Lahore, Lahore.
Full name of responsible person
Muhammad Riwan
Street address
Raiwind Road
City
LAHORE
Postal code
55150
Phone
+92 61 6521475
Email
rizwanakhter66@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
university of Lahore, Lahore
Full name of responsible person
Waqar Afzal
Street address
Raiwind road lahore
City
LAHORE
Postal code
55150
Phone
+92 42 32591427
Email
Waqarafzal621@gmail.com
Grant name
Muhammad Rizwan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of Lahore, Lahore
Proportion provided by this source
20
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
university of Lahore, Lahore
Full name of responsible person
Muhammad Rizwan
Position
lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Raiwind road lahore
City
LAHORE
Province
Punjab
Postal code
55150
Phone
+92 42 32591427
Email
rizwanakhter66@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
university of Lahore, Lahore
Full name of responsible person
Waqar Afzal
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Raiwind road lahore
City
LAHORE
Province
Punjab
Postal code
55150
Phone
+92 42 32591427
Email
Waqarafzal621@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
physiotherapy department mayo hospital, Lahore
Full name of responsible person
Ayesha Razzaq
Position
physiotherapy
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Neela Gumbat
City
Lahore
Province
Punjab
Postal code
36121
Phone
+92 61 6521475
Email
drayesharazzak@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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effects of Temporomandibular joint exercises on pain, range of motion and functional disability in patient with non-specific neck pain
When the data will become available and for how long
study is completed and become available after its publication
To whom data/document is available
person in academic institute. Patient data will not be shown
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication it could be used in request.
From where data/document is obtainable
+923367595206 from the University office and Responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
can be on call or mail It will be only used in confidential way for improving research and benefit of humanity
Comments
data can bee provided on request
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