Protocol summary

Study aim
Comparison of the effects of six weeks of McKenzie and PNF exercises on shoulder posture, pain, function, and jaw noise in women aged 20 to 40 with upper crossed syndrome.
Design
The sample size is 42 participants, with 14 individuals in each of the three groups control, McKenzie, and PNF assigned through simple randomization.
Settings and conduct
Volunteers are recruited from the School of Dentistry, Tehran University of Medical Sciences, and the International Campus.
Participants/Inclusion and exclusion criteria
Voluntary women aged 20 to 40 with upper crossed syndrome and temporomandibular joint disorder (TMD), with a BMI between 18 and 25 No use of medications or other treatments No severe spinal problems, fractures, surgeries, or severe pelvic and lumbar deformities No rheumatologic, neurological disorders, or systemic diseases No significant temporomandibular joint issues and no history of traumatic injury to the jaw or neck No fibromyalgia syndrome No physiotherapy or similar treatments in the past 3 months Diagnosed with TMD by a specialist physician Angle criteria: Forward head posture ≤ 50 degrees, forward shoulder posture ≥ 52 degrees, and hyper kyphosis ≥ 40 degrees.
Intervention groups
There are three groups: McKenzie, PNF, and control. The first two groups perform exercises for 30 to 45 minutes, three days a week, for six weeks, and are evaluated before and after the intervention. The control group is only evaluated after six weeks.
Main outcome variables
Changes in forward head angle, forward shoulder angle, kyphosis, and changes in jaw symptoms including noise, pain, and Jaw weakness.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250504065596N1
Registration date: 2025-08-27, 1404/06/05
Registration timing: prospective

Last update: 2025-08-27, 1404/06/05
Update count: 0
Registration date
2025-08-27, 1404/06/05
Registrant information
Name
Sarvenaz Shabani Panbeh Choleh
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 11 3375 6251
Email address
s.shabanipanbeh@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of McKenzie Exercises and PNF on Angles, Performance, and Symptoms in Women with Upper Crossed Syndrome and Temporomandibular Joint Disorder: a randomized clinical trial
Public title
Comparison of the Effects of Two Types of Exercise on Women with Upper Crossed Syndrome and Temporomandibular Joint Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Voluntary Participation Body Mass Index between 18 and 25 Diagnosis of TMD based on the specialist's assessment At least one month has passed since the onset of TMD pain "Forward head posture ≤ 50 degrees, forward shoulder posture ≥ 52 degrees, and hyper kyphosis ≥ 40 degrees." Female participants only 20 to 40 years old Presence of clicking sounds in the temporomandibular joint(TMJ) Functional disability of the temporomandibular joint (TMJ) Presence of pain in the temporomandibular joint (TMJ) and associated structures
Exclusion criteria:
Use of medication or other interventions Presence of specific spinal pathologies such as severe disc herniation (grade II or III) History of spinal fracture or surgery Presence of severe deformities in the lumbar spine or pelvis Presence of rheumatologic disorders Presence of sequestrated (migrated) disc displacement, TMJ osteoarthritis, or arthritis according to DC/TMD criteria History of traumatic injuries to the mandible or cervical spine Presence of fibromyalgia syndrome Presence of systemic diseases (rheumatoid arthritis, systemic lupus erythematosus, or psoriatic arthritis) Presence of neurological disorders History of any treatment (physiotherapy, splint therapy, or acupuncture) within 3 months prior to the study
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization: Participants, after confirming the inclusion and exclusion criteria, are randomly assigned to the intervention and control groups using a randomization table. The randomization table consists of a sequence of numbers or letters generated by randomization software, and each participant is assigned to a group based on their enrollment number. This method minimizes bias and ensures an equal distribution of characteristics between the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University
Street address
No. 91, Corner of Yousef Alley, Before Dr. Gharib Street, Forsat Shirazi Street, Eskandari North Street, Azadi Street
City
Tehran
Province
Tehran
Postal code
1419794531
Approval date
2025-04-19, 1404/01/30
Ethics committee reference number
IR.SBU.REC.1404.007

Health conditions studied

1

Description of health condition studied
Temporomandibular Joint Disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders

2

Description of health condition studied
Upper Cross Syndrom
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Forward Head
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Photogrammetry method for evaluating upper crossed syndrome

2

Description
Shoulder Forward
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Photogrammetry method for evaluating upper crossed syndrome

3

Description
Kyphosis
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Photogrammetry method for evaluating upper crossed syndrome

4

Description
Temporomandibular joint noise
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Diagnostic Criteria for Temporomandibular Disorders

5

Description
Temporomandibular joint pain
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Diagnostic Criteria for Temporomandibular Disorders

6

Description
Temporomandibular joint function
Timepoint
One day before the start of the study, followed by six weeks of training, and then one day after the end of the training
Method of measurement
Diagnostic Criteria for Temporomandibular Disorders

Secondary outcomes

empty

Intervention groups

1

Description
Control group: No intervention is applied. Only assessment of Upper Crossed Syndrome and Temporomandibular Joint Disorder (TMD) is performed initially, and then reassessed six months later.
Category
Treatment - Other

2

Description
Intervention group one: The McKenzie exercise program is performed as a cervical stabilizing exercise. The purpose of the McKenzie exercise program is to eliminate pain and restore postural control and balance. The training protocol lasts for 6 weeks, 3 sessions per week, totaling 16 sessions, and for warm-up 10 minutes and for cool-down 5 minutes in total 15 minutes and 30 minutes of exercise time will be considered. Sufficient explanations and demonstrations were provided to ensure correct exercise performance, and the training was conducted under the supervision of the researcher. The subjects performed 7 movements at maximum static strength for 7 seconds and in total 20 repetitions with 3 seconds rest between each movement. The exercise intensity increased each week by adding 10% to the number of repetitions. The exercises included: chin tuck in sitting position, cervical extension in sitting or standing position, lifting the head in supine position, turning the head to the left and right in supine position, lateral flexion to the left and right, chin tuck with head rotation and looking toward the shoulder, cervical flexion in sitting position.
Category
Treatment - Other

3

Description
Intervention group two: The PNF program consists of a total of eight therapeutic exercises. Considering the alignment of the cervical spine and pain in the temporomandibular joint, the position will be performed with greater support. All exercise programs were designed based on the basic principles of PNF, the fundamental procedures, and the philosophy of PNF, and the PNF patterns and techniques were adapted to the hypothesis of activity limitation. The weekly programs were adjusted by combining three to four exercise programs according to the patient’s level of adaptation to the program. Before starting the exercise program, general explanations and precise instructions regarding deep breathing will be given to the patient, and when the patient reports pain or fatigue, the exercise will be stopped for 2 to 3 minutes of rest. Rest will not be considered during the entire exercise period. In the last 3 weeks, all exercises will be performed, and the exercise intensity will be increased each week by adding 10% to the number of repetitions. The training protocol lasts for 6 weeks, 3 sessions per week, totaling 16 sessions, and for warm-up 10 minutes and for cool-down 5 minutes, in total 15 minutes, and 30 minutes of exercise time will be considered. Sufficient explanations and demonstrations were provided to ensure correct exercise performance, and the training was conducted under the supervision of the researcher. The exercises included: stretching of the upper cervical extensor muscles, reciprocal inhibition of suboccipital muscles with strengthening of suprahyoid muscles, increasing stability in the corrected position of the cervical spine and temporomandibular joint (TMJ) with device, tongue exercise in the corrected cervical position, increasing mobility of the mandible in the corrected cervical position, mouth opening, biting an apple, and holding a towel behind the neck while opening the mouth.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Sarvenaz Shabani Panbecholeh
Street address
School of Dentistry Tehran University of Medical Sciences End of North Kargar Street, Adjacent to Atomic Energy Organization, Before Hakim Expressway (East Exit) Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
dentistry@tums.ac.ir

2

Recruitment center
Name of recruitment center
Tehran International Campus School of Dentistry
Full name of responsible person
Sarvenaz Shabani Panbecholeh
Street address
School of Dentistry, International Campus, Mahan St. (Shahid Zolfi), Opposite Shariati Park, Beginning of Khani Abad-e No, Navab Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Fax
Email
dentistyic@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Amir Hossein Barati
Street address
Shahid Shahriari Square, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
pr-office@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
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
Full name of responsible person
Sarvenaz Shabani Panbecholeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective movements and sports pathology
Street address
No. 91, Corner of Yousef Alley, Before Dr. Gharib Street, Forsat Shirazi Street, Eskandari North Street, Azadi Street
City
Tehran
Province
Tehran
Postal code
1419794531
Phone
+98 21 6659 5554
Email
sarvenazshabani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sarvenaz Shabani Panbecholeh
Position
student
Latest degree
Master
Other areas of specialty/work
Master of Science in Corrective Movements and Sports Injury Pathology
Street address
No. 91, Corner of Yousef Alley, Before Dr. Gharib Street, Forsat Shirazi Street, Eskandari North Street, Azadi Street
City
Tehran
Province
Tehran
Postal code
1419794531
Phone
+98 21 6659 5554
Email
sarvenazshabani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sarvenaz Shabani Panbecholeh
Position
student
Latest degree
Master
Other areas of specialty/work
Master of Science in Corrective Movements and Sports Injury Pathology
Street address
No. 91, Corner of Yousef Alley, Before Dr. Gharib Street, Forsat Shirazi Street, Eskandari North Street, Azadi Street
City
Tehran
Province
Tehran
Postal code
1419794531
Phone
+98 21 6659 5554
Email
sarvenazshabani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the factors considered in the research are averaged after statistical analysis
When the data will become available and for how long
Access started in 1405
To whom data/document is available
all people
Under which criteria data/document could be used
If you are conducting related research to help other people
From where data/document is obtainable
email to sarvenazshabani@yahoo.com
What processes are involved for a request to access data/document
If you provide documented proof of your research work, it is possible to send data quickly, but there is no right to copy the data.
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