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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05431829
Other study ID # REC-FSD-00255
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 12, 2022

Study information

Verified date June 2022
Source Riphah International University
Contact Muhammad Kashif
Phone +92418777210
Email kashif.shaffi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 12, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1st day
Primary 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 1st day
Primary 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. 1st day
Primary 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. 1st day
Primary 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. 1st day
Primary 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. 1st day
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