History
# Registration date Revision Id
2 2021-07-08, 1400/04/17 190884
1 2019-06-29, 1398/04/08 95063
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The effect of cervical treatment on pain, range of motion, and ultrasonic findings in patients with temporomandibular disorders
Design
This study included two groups: control group and intervention group. study design: randomized control trial with control group, parallel group, non-blinded .
Settings and conduct
Place of study: Iran University of Medical Sciences, School of rehabilitation, Ultrasonography laboratory Method: This study included two groups: control group and intervention group. Control group: The control group will receive the routine physiotherapy for six weeks. Intervention group: The intervention group will receive the routine physiotherapy AND treatment for cervical dysfunction for six weeks. two groups receive treatment two times per week during six weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-Individuals with age between 20-40 years 2-Individuals with tempromandibular disorders Exclusion criteria: 1-Individuals with disk herniation in cervical area 2-Individuals with neurology diseases as Parkinson, MS 3-Unwillingness to participate in the study
Intervention groups
Control group: The control group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound 1MHZ and TENS (Acupuncture like) for six weeks. The patients in control group receive routine physiotherapy two times per week during six weeks. Intervention group: The intervention group will receive the routine physiotherapy AND treatment for cervical dysfunction for six weeks. The patients in intervention group receive routine physiotherapy AND treatment for cervical dysfunction two times per week during six weeks
Main outcome variables
pain; cervical range of motions, mouth opening; disk position

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190621043964N1
Registration date: 2019-06-29, 1398/04/08
Registration timing: prospective

Last update: 2019-06-29, 1398/04/08
Update count: 1
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Khaled Rezaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
rezaie.kh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cervical treatment on pain, range of motion, and ultrasonic findings in patients with temporomandibular disorders
Public title
The effect of cervical treatment on function of people with temporomandibular pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with age between 20-40 years Individuals with tempromandibular disorders
Exclusion criteria:
Individuals with disk herniation in cervical area Individuals with neurology diseases as Parkinson, MS Unwillingness to participate in the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: randomized block design, block size:4, ratio 1:1 Randomization tool: software
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
Ir.Iums.Rec.1397.1054

Health conditions studied

1

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

Primary outcomes

1

Description
pain
Timepoint
Before the intervention(baseline), six weeks and three months later
Method of measurement
Visual analog scale

2

Description
Cervical range of motion
Timepoint
Before the intervention(baseline) and six weeks and three months later
Method of measurement
Goniometer

3

Description
Mouth opening
Timepoint
Before the intervention(baseline), six weeks and three months later
Method of measurement
Ruler

4

Description
Lateral translation of mandible
Timepoint
Before the intervention(baseline), six weeks and three months later
Method of measurement
Ruler

5

Description
Disk position
Timepoint
Before the intervention(baseline), six weeks and three months later
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound ultrasound 1MHZ and TENS (Acupuncture like) AND treatment for cervical dysfunction for six weeks. The patients in intervention group receive routine physiotherapy AND treatment for cervical dysfunction two times per week during six weeks
Category
Rehabilitation

2

Description
Control group: The control group will receive the routine physiotherapy such as massage, mobilization temporomandibular joint, therapeutic ultrasound 1MHZ and TENS (Acupuncture like) for six weeks. The patients in control group receive routine physiotherapy two times per week during six weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Khaled Rezaie
Street address
Shariati Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
rezaie.kh@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Malakooti Seyyed Kazem
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Rezaie Khaled
Position
Phd student of Physiotherapy, Iran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
+98 21222280512
Email
rezaie.kh@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amiri Ali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
+98 21 2222 7124
Email
amiri.alipt10@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Rezaie Khaled
Position
Phd student of Physiotherapy, Iran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷۱۵۴۵۹
Phone
+98 21222280512
Email
rezaie.kh@iums.ac.ir

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The original data is shared in thesis format
When the data will become available and for how long
After defense of thesis, the original data is shared in thesis format.
To whom data/document is available
Academic researchers, physiotherapists
Under which criteria data/document could be used
In order to use clinical results, the original data is shared in thesis format.
From where data/document is obtainable
Library of the faculty of rehabilitation rehabilitation Sciences of Iran University of Medical Sciences
What processes are involved for a request to access data/document
Referral to library of the faculty of rehabilitation Sciences of Iran University of Medical Sciences
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