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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05432037
Other study ID # REC-FSD-00245
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 12, 2023

Study information

Verified date May 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to translate and culturally adapt Fear Avoidance Belief Questionnaire into the Urdu language and to investigate the reliability and validity in the Pakistani population and check its correlation with Visual Analog Scale , Ronald Morris Questionnaire, Quebec Back Pain Disability Scale and Hospital Anxiety and Depression scale .


Description:

As per preceding commendation, Fear Avoidance Belief Questionnaire will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among low back pain population, Fear Avoidance Belief Questionnaire will be conducted in 180 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Fear Avoidance Belief Questionnaire, Hospital anxiety and depression scale, Ronald Morris questionnaire, Quebec pain rating scale and numeric pain rating scale will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Fear Avoidance Belief Questionnaire will be evaluated for content validity, construct validity, criterion validity and responsiveness.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date July 12, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients or the ones next to them who gave informed consent - Participants with complain of low back pain for more than 3 months. - Age at least above 18 years. Exclusion Criteria: - Inability to understand or follow the instructions of the Fear Avoidance Belief Questionnaire. - Any musculoskeletal pathologies - Suffering from any cardiovascular pathologies - Any history of tumor and cancer - Any history of fracture - Any histories of infections - Any history of neurological disorders - Having any spinal deformity

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 Fear Avoidance Belief Questionnaire The fear avoidance belief questionnaire is a standardized clinical assessment tool to investigate patients work and activity specific fear-avoidance beliefs and physical disability related to work. The Fear Avoidance Belief Questionnaire consists of 2 sub-scales. The Physical Activity sub-scale and The Work sub-scale. 1st day
Primary Hospital Anxiety and Depression scale It is the scale used for evaluation of anxiety and depression symptoms related to disease. The Hospital Anxiety and Depression scale is the objective assessment of disease related anxiety and depression symptoms based on 14 items. 7 questions for each depression and anxiety sub-scales.
Scoring ranges from 0-3. Total scores are from 0-21. Normal or no anxiety scores from 0-7, 8-10 mild to moderate anxiety, 11-21 moderate to severe anxiety.
1st day
Primary Ronald Morris Questionnaire Ronald Morris Questionnaire is the scale used for evaluation of level of disability among patients of back pain. Ronald Morris questionnaire is a self-administrated disability measurement based on 24 items. Higher level of disability is represented by greater score on 24-points scale. 1st day
Primary Quebec Pain Rating Scale The Quebec Back Pain Disability Scale is a 20-item self-administered device designed to assess the level of practical disability in people with low back pain. The scale is a reliable and accurate measure used to monitor the progress of individual patients participating in treatment or rehabilitation programs. 1st day
Primary Visual Analog Scale Scores of Visual Analog Scale are based on self-reported measures of symbols that are recorded with a length of 10 as well as a written mark placed in one place. The centimetre line that represents the continuity between the two ends of the scale - from "no pain" on the left end of the scale (0 cm) and the "worst pain" on the right end of the scale (10 cm). 1st day
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