NCT04849442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 10, 2021

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cervical spine range of motion by CROM

    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 Outcomes (1)

  • TMJ vertical opening

    "through study completion, an average of 3 months"

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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 )

You may qualify if:

  • Between the ages of 20 and 40
  • Female and Male
  • Suffering from a reduced cervical ROM
  • No reported TMJ pain

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Cairo, 34518, Egypt

Location

MeSH Terms

Conditions

Musculoskeletal PainNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed El-Sayed, Assistant lecturer

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 19, 2021

Study Start

June 1, 2019

Primary Completion

August 30, 2019

Study Completion

September 30, 2019

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations