Temporomandibular DisorderNCT05431829
Urdu Version of Fonseca Anamnestic Index: Reliability and Validity Study
An observational study of Temporomandibular Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study is to translate and culturally adapt Fonseca Anamnestic Index into Urdu language and to investigate the reliability and validity in Pakistani population over the age 18 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorder
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Jul 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani population with or without temporo-mandibular disorders over the age 18-80 years and both genders.
Who may be able to join
- Patient with the age of 18 years.
- Having any previous history of temporo-mandibular joint pain
- Having any current condition of temporo-mandibular disorders.
- Both Genders are included equally.
Who cannot join
- Inability to understand or follow the instructions of the Fonseca Anamnestic Index.
- Suffering from any neurological condition.
- Suffering from any unstable medical condition.
- Patients with rheumatoid arthritis were also excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ripah International University
Faisalabad, Punjab Province, 38000
Muhammad Kashif, 0418777210, kashif.shaffi@gmail.com
About this study
Official title: Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Fonseca Anamnestic Index in Pakistani Population
The aim of study is to translate and culturally adapt Fonseca Anamnestic Index into Urdu language and to investigate the reliability and validity in Pakistani population over the age 18 years.
Read the detailed description
The English version of the Fonseca Anamnestic Index will be translated and culturally adapted as per previous recommendation. In Pakistani general population, Urdu Version of Fonseca Anamnestic Index will distributed among 140 participants choose by random sampling technique based on pre-defined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu Version of Fonseca Anamnestic Index questionnaire will be filled on the same day, by two observers, and for the Inter-Observers assessment, with an interval of 30 minute between the first and the second application. Third assessment will carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- re-test reliability will be assessed using an intra-class correlation coefficient. The Urdu Version of Fonseca Anamnestic Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.
- Conditions
- Temporomandibular Disorder
- Keywords
- Fonseca Anamnestic Index, Urdu Version, Reliability, Validity, Temporomandibular Disorder, General Population
- Medical subject headings
- Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Fonseca Anamnestic Index
It is a scale proposed to identify and determine the severity of temporo-mandibular disorder through 10 question being designed in the form of a questionnaire which is then to be filled and completed by the population.
Measured: 1st day
Numeric Pain Rating Scale
The numeric pain rating scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain
Measured: 1st day
Short Form - 36
The Short Form - 36 which is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers.
Measured: 1st day
Dizziness Handicap Inventory
Dizziness and vertigo sensations were measured with the dizziness handicap inventory, which is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders.
Measured: 1st day
Headache impact Test-6
The headache impact test is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
Measured: 1st day
Neck Disability Index
The neck disability index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 May 2021
- Primary completion10 Jul 2022 (estimated)
- Study completion12 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431829
- Sponsor's protocol ID
- REC-FSD-00255
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Fonseca Anamnestic Index in Pakistani Population
- ClinicalTrials.gov ID
- NCT05431829
- Acronym / sponsor ID
- REC-FSD-00255
- Conditions
- Temporomandibular Disorder
- Keywords
- Fonseca Anamnestic Index, Urdu Version, Reliability, Validity, Temporomandibular Disorder, General Population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 12 Jul 2022 (estimated)
- First posted
- 24 Jun 2022 (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.
The aim of study is to translate and culturally adapt Fonseca Anamnestic Index into Urdu language and to investigate the reliability and validity in Pakistani population over the age 18 years.
Detailed description
The English version of the Fonseca Anamnestic Index will be translated and culturally adapted as per previous recommendation. In Pakistani general population, Urdu Version of Fonseca Anamnestic Index will distributed among 140 participants choose by random sampling technique based on pre-defined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu Version of Fonseca Anamnestic Index questionnaire will be filled on the same day, by two observers, and for the Inter-Observers assessment, with an interval of 30 minute between the first and the second application. Third assessment will carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- re-test reliability will be assessed using an intra-class correlation coefficient. The Urdu Version of Fonseca Anamnestic Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani population with or without temporo-mandibular disorders over the age 18-80 years and both genders.
Key inclusion criteria (4 listed)
- Patient with the age of 18 years.
- Having any previous history of temporo-mandibular joint pain
- Having any current condition of temporo-mandibular disorders.
- Both Genders are included equally.
Key exclusion criteria (4 listed)
- Inability to understand or follow the instructions of the Fonseca Anamnestic Index.
- Suffering from any neurological condition.
- Suffering from any unstable medical condition.
- Patients with rheumatoid arthritis were also excluded
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
Fonseca Anamnestic Index
Time frame: 1st day
It is a scale proposed to identify and determine the severity of temporo-mandibular disorder through 10 question being designed in the form of a questionnaire which is then to be filled and completed by the population.
Numeric Pain Rating Scale
Time frame: 1st day
The numeric pain rating scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain
Short Form - 36
Time frame: 1st day
The Short Form - 36 which is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers.
Dizziness Handicap Inventory
Time frame: 1st day
Dizziness and vertigo sensations were measured with the dizziness handicap inventory, which is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders.
Headache impact Test-6
Time frame: 1st day
The headache impact test is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
Neck Disability Index
Time frame: 1st day
The neck disability index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- 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.
Muhammad Kashif study chair
Riphah International University
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 Temporomandibular Disorder, run by Riphah International University at 1 site in Pakistan.
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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Kashif (+92418777210, kashif.shaffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fonseca Anamnestic Index (time frame: 1st day). The study lists 6 primary outcomes in all. 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 24 Jun 2022.