Protocol summary
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Study aim
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The effects of routine treatment and manual therapy in patients with temporomandibular disorders
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Design
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This study included two groups: control group and intervention group.
study design: randomized control trial with control group, parallel group.
The patients and outcome assessor will be blind
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Settings and conduct
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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 including gentle massage over the masseter muscle, ultrasound 1 MHz and TENS.
The intervention group will receive the routine physiotherapy AND manual therapy of temporomandibular joint and upper cervical .
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1-unilateral or bilateral TMD according to the DC/TMD
2-pain more than 3 based on visual analog scale
Exclusion criteria:
1-a traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months
2-history of the orofacial surgery during the last 6 months
3-neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
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Intervention groups
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Control group: The control group will receive the routine physiotherapy such as massage, therapeutic ultrasound 1MHZ and TENS for eight weeks.
Intervention group: The intervention group will receive the routine physiotherapy and manual therapy of TMJ and cervical spine.
The patients in both groups will receive routine physiotherapy 10 sessions during eight weeks.
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Main outcome variables
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pain; maximum mouth opening, cervical flexion and extension range of motions,
General information
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Reason for update
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Lack of time in coronary conditions
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190621043964N1
Registration date:
2019-06-29, 1398/04/08
Registration timing:
prospective
Last update:
2021-07-19, 1400/04/28
Update count:
1
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Registration date
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2019-06-29, 1398/04/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-01, 1398/08/10
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Expected recruitment end date
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2021-02-01, 1399/11/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of routine treatment and manual therapy on pain, and range of motion in patients with temporomandibular disorders
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Public title
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The effects of routine treatment and manual therapy in people with temporomandibular disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Individuals with tunilateral or bilateral TMD according to the DC/TMD
pain more than 3 based on visual analog scale
Exclusion criteria:
traumatic injury that caused the symptoms in the temporomandibular joint and the orofacial region during the last three months
history of the orofacial surgery during the last 6 months
neurological and systemic diseases such as rheumatoid arthritis; Parkinson; multiple sclerosis, positional vertigo, pregnancy, and severe deformity in the jaw or face region
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Block balanced randomization design, block size:4, ratio 1:1
Randomization tool: Random allocation will be performed using the website of www.randomization.com.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-28, 1397/08/06
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Ethics committee reference number
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Ir.Iums.Rec.1397.1054
Health conditions studied
1
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Description of health condition studied
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Temporomandibular dysfunction
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ICD-10 code
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M26.6
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ICD-10 code description
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Temporomandibular joint disorders
Primary outcomes
1
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Description
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pain
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Timepoint
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At the baseline, after the end of the treatment, and after a one-month follow-up period
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Method of measurement
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Visual analog scale
Secondary outcomes
1
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Description
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Maximum mouth opening
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Timepoint
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At the baseline, after the end of the treatment, and after a one-month follow-up period
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Method of measurement
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caliper
2
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Description
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Cervical flexion and extension ROM
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Timepoint
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At the baseline, after the end of the treatment, and after a one-month follow-up period
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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Control group: The control group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS for ten sessions during 8 weeks.
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Category
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Rehabilitation
2
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Description
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Intervention group: The intervention group will receive the routine physiotherapy such as gentle massage over the masseter muscles , therapeutic ultrasound 1MHZ and TENS and manual therapy of the TMJ and upper cervical spine. This group will receive the interventions for ten sessions during 8 weeks.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The original data is shared in thesis format
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When the data will become available and for how long
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After defense of thesis, the original data is shared in thesis format.
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To whom data/document is available
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Academic researchers, physiotherapists
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Under which criteria data/document could be used
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In order to use clinical results, the original data is shared in thesis format.
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From where data/document is obtainable
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Library of the faculty of rehabilitation rehabilitation Sciences of Iran University of Medical Sciences
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What processes are involved for a request to access data/document
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Referral to library of the faculty of rehabilitation Sciences of Iran University of Medical Sciences
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Comments
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