- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849442
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders
April 13, 2021 updated by: Mohamed Salah El-Sayed, Horus University
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders: An Observational Study
Since TMJ and cervical pain incidence are rising and both structures are highly interrelated anatomically and functionally.
And yet no standard protocol for TMD therapy The objective of this study is to state if there is a correlation between TMD and cervical dysfunction.
To help reach a better diagnosis and a more holistic treatment.
Forty volunteers (15 male and 25 female) between the ages of 20 to 40 were recruited.
Cervical ROM was measured in all directions (rotation, flexion and extension, and sidebending) by CROM device, and a 10 cm plastic ruler marked in both centimeters and millimeters was used to measure TMJ vertical opening.
Study Overview
Status
Completed
Conditions
Detailed Description
Background: The incidence of temporomandibular dysfunction has been rapidly increasing in the past years especially among women and still no definite treatment protocol and that's due to the inter lapping of anatomy and neurology of this joint with other structures all over the body.
The cervical spine dysfunction has a high incidence as well, and they are common to coexist as they are highly interrelated.
Objective: The objective of this study is to emphasize the interrelation between cervical dysfunction and TMJ dysfunction by examining the relationship between cervical spine ROM and TMJ vertical opening ROM to provide better recognition of the etiology of TMJ dysfunction thus a holistic intervention.
Materials and methods: It is a bivariate correlational research design.
Forty subjects between the age of 20 -40 years (15male/ 25females) were recruited.
Cervical ROM was measured by CROM device for all 6 cervical movements.
The TMJ vertical mouth opening was measured by a 10 cm ruler.
The CROM will be used consistent with standard clinical procedures, with 3 takes for each measurement to decrease human error.
The measurements were taken one shot.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 34518
- Outpatient clinic, Faculty of Physical Therapy, Cairo university
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients included in this study were recruited at the outpatient clinic of physical therapy and El Kasr El Einy Hospital from June 2019 till August 2019.
The standard procedure is that patients fill out an admission form and undergo an intake assessment.
After examination, the patient, who had a cervical dysfunction, was asked if they would be willing to undergo an assessment for this study.
Forty volunteers (15 male and 25 female) between the ages of 20 to 40 (mean 27.05 +- 3.93 )
Description
Inclusion Criteria:
- Between the ages of 20 and 40
- Female and Male
- Suffering from a reduced cervical ROM
No reported TMJ pain
Exclusion Criteria:
- 1) Tumor (anywhere in the body)
- Recent trauma to the neck, torso or upper limb
- Active inflammation in the cervical region, upper thoraxic spine and chest or upper limb
- Recent use of orthodontics prostheses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical spine range of motion by CROM
Time Frame: "through study completion, an average of 3 months"
|
measuring the change of cervical range of motion in all directions (rotation, flexion and extension, and side bending)
|
"through study completion, an average of 3 months"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TMJ vertical opening
Time Frame: "through study completion, an average of 3 months"
|
measuring the change of TMJ vertical opening by the second device used was a 10 cm plastic ruler marked in both centimeters and millimeters was used in the measurements, with (ICC 2,K) varied from 0.90 to 1.0, placed between the upper and lower edges of the central incisors
|
"through study completion, an average of 3 months"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed El-Sayed, Assistant lecturer, Horus University in Egypt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
August 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
April 10, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- msalah_bfpt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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