Low Back PainNCT05432037
Urdu Version of Fear Avoidance Belief Questionnaire: Reliability and Validity Study
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population for this study will be reported cases of low back pain.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Evaluation of Cultural Adaptation and Psychometric Properties of Urdu Version of Fear Avoidance Belief Questionnaire
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 .
Read the detailed 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.
- Conditions
- Low Back Pain
- Keywords
- Fear Avoidance Belief Questionnaire, Urdu Version, Reliability, Validity, Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
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).
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 posted27 Jun 2022
- Study start30 May 2021
- Primary completion10 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 180 participants (actual)
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
- NCT05432037
- Sponsor's protocol ID
- REC-FSD-00245
- Status last verified
- May 2024
- First submitted
- 20 Jun 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cultural Adaptation and Psychometric Properties of Urdu Version of Fear Avoidance Belief Questionnaire
- ClinicalTrials.gov ID
- NCT05432037
- Acronym / sponsor ID
- REC-FSD-00245
- Conditions
- Low Back Pain
- Keywords
- Fear Avoidance Belief Questionnaire, Urdu Version, Reliability, Validity, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 27 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 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 .
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population for this study will be reported cases of low back pain.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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
Fear Avoidance Belief Questionnaire
Time frame: 1st day
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.
Hospital Anxiety and Depression scale
Time frame: 1st day
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.
Ronald Morris Questionnaire
Time frame: 1st day
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.
Quebec Pain Rating Scale
Time frame: 1st day
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.
Visual Analog Scale
Time frame: 1st day
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).
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 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
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 Low Back Pain, 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 3 inclusion and 8 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 7 May 2024. 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?
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?
Fear Avoidance Belief Questionnaire (time frame: 1st day). The study lists 5 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 7 May 2024.