Musculoskeletal PainNCT04849442
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders
An observational study of Musculoskeletal Pain and TMJ Pain, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Musculoskeletal Pain, TMJ Pain, Cervical Pain
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Adult
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 )
Who may be able to join
- Between the ages of 20 and 40
- Female and Male
- Suffering from a reduced cervical ROM
- No reported TMJ pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo University
Cairo, 34518
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Pain, TMJ Pain, Cervical Pain
- Medical subject headings
- Musculoskeletal Pain, Neck Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "through study completion, an average of 3 months"
Secondary outcomes (1)
TMJ vertical opening
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
Measured: "through study completion, an average of 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jun 2019
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El-Sayed, Horus University
- Investigators
- Mohamed El-Sayed, Assistant lecturer, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849442
- Sponsor's protocol ID
- msalah_bfpt
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders: An Observational Study
- ClinicalTrials.gov ID
- NCT04849442
- Acronym / sponsor ID
- msalah_bfpt
- Conditions
- Musculoskeletal Pain, TMJ Pain, Cervical Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- 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 )
Key inclusion criteria (4 listed)
- Between the ages of 20 and 40
- Female and Male
- Suffering from a reduced cervical ROM
- No reported TMJ pain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
TMJ vertical opening
Time frame: "through study completion, an average of 3 months"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed El-Sayed, Assistant lecturer principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and TMJ Pain, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical spine range of motion by CROM (time frame: "through study completion, an average of 3 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.