Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders

• ClinicalTrials.gov Identifier: NCT04849442
• Recruitment Status: Completed
• First Posted: April 19, 2021
• Last Update Posted: April 19, 2021
• Sponsor: Horus University
• Information provided by (Responsible Party): Mohamed Salah El-Sayed, Horus University

Study Description

Brief Summary:

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.

Condition or disease
Musculoskeletal Pain; TMJ Pain; Cervical Pain

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 Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders: An Observational Study
• Actual Study Start Date: June 1, 2019
• Actual Primary Completion Date: August 30, 2019
• Actual Study Completion Date: September 30, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes 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 )

Criteria

Inclusion Criteria:

1. Between the ages of 20 and 40
2. Female and Male
3. Suffering from a reduced cervical ROM

4. No reported TMJ pain

   Exclusion Criteria:

   • 1) Tumor (anywhere in the body)
5. Recent trauma to the neck, torso or upper limb
6. Active inflammation in the cervical region, upper thoraxic spine and chest or upper limb
7. Recent use of orthodontics prostheses

Contacts and Locations

Locations

Egypt

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Cairo, Egypt, 34518

Sponsors and Collaborators

Horus University

Investigators

• Principal Investigator: Mohamed El-Sayed, Assistant lecturer; Horus University in Egypt

More Information

• Responsible Party: Mohamed Salah El-Sayed, Principal Investigator, Horus University
• ClinicalTrials.gov Identifier: NCT04849442
• Other Study ID Numbers: msalah_bfpt
• First Posted: April 19, 2021
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Musculoskeletal Pain; Neck Pain; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations