An observational study in Chronic Low Back Pain, sponsored by Bayero University Kano, Nigeria. Completed at 1 site in Nigeria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by Bayero University Kano, Nigeria · Observational
Oswestry Disability Index (ODI), Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire (RMDQ), SF-12 Health Survey, Pain Catastrophizing Scale (PCS), Fear-Avoidance Beliefs Questionnaire (FABQ), Global Rating of Change Scale and Back Beliefs Questionnaire (BBQ) are important and widely used validated patient self-reported measures commonly used in clinical trials and health research involving patients with low back pain (LBP). However, to date, validated Hausa versions of these tools are unavailable for use despite not only Hausa language is commonly spoken in Nigeria but in other parts of the world.
The purpose of this study is to perform, using evidence-based guidelines, translation, cultural adaptation and validation of the ODI, NPRS, RMDQ, SF-12 health survey, FABQ, PCS, GROC and BBQ into Hausa language among patients with LBP in Northern Nigeria.
This study will test the psychometric properties (i.e validity; reliability, and ceiling effect) of the ODI-H, NPRS, RMDQ-H, SF-12-H, FABQ-H, PCS-H, GROC and BBQ-H in Hausa-speaking patients with LBP. Rural and urban participants with LBP will be recruited purposively. Copies of the translated Hausa versions of the NPRS, ODI, RMDQ, SF-12, FABQ, PCS, BBQ as well as VAS for pain and disability will be self or interviewer-administered. Lumbopelvic mobility using finger-floor distance test (FFD) will be also measured. The Hausa versions of the ODI, NPRS, RMDQ, SF-12, FABQ, PCS, GROC and BBQ will be administered again a week after.
Data will be analysed using descriptive, correlation, and factorial analysis on IBM SPSS (version 23.0) at alpha level of 0.05.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Bayero University Kano, Nigeria is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Adults with CLBP attending either rural or urban physiotherapy clinics in Kano State, Northern Nigeria.
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Exclusion Criteria:
Initial evaluation involves the application of Hausa ODI, NPRS, RMDQ, SF-12, PCS, GROC, BBQ, VAS for pain and disability, and FFD.
Application of the Hausa versions of ODI, NPRS, RMDQ, SF-12, PCS, GROC and BBQ one week after initial evaluation
Change in functional disability
Functional disability will be measured by the Hausa Oswestry disability index (ODI-H). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability.
Time frame: Baseline and 1 week after baseline
Change in pain intensity
Pain intensity will be measured by the Hausa Numeric Pain Rating Scale (NPRS-H). The score ranges from 0 to 10, with 0 indicating "No Pain" and 10 "Worst Imaginable Pain".
Time frame: Baseline and 1 week after baseline
Change in functional disability
Functional disability will be measured by the Hausa Roland-Morris Disability Questionnaire (RMDQ-H). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability.
Time frame: Baseline and 1 week after baseline
Change in quality of life
Quality of life will be measured using the Hausa SF-12 Health Hurvey (SF-12-H). The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Time frame: Baseline and 1 week after baseline
Change in fear-avoidance beliefs
Fear-avoidance beliefs will be measured by the Hausa fear avoidance beliefs
Time frame: Baseline and 1 week after baseline
Change in pain catastrophization
Pain catastrophization will be measured by the Hausa Pain Catastrophizing Scale (PCS-H). The scale consists of 13 items rated on 5-point ordinal scale (0-5).The total score ranges from 0-52 with higher score indicating more catastrophic thoughts.
Time frame: Baseline and 1 week after baseline
Change in back beliefs
Back pain beliefs will be evaluated by the Hausa Back Beliefs Questionnaire (BBQ-H). The questionnaire consists of 14 items with 9 items ranked on a 5 point scale and used to calculate a final score from 9 to 45. Higher scores are indicative of better LBP beliefs and indicate the potential of a better ability to cope with LBP.
Time frame: Baseline and 1 week after baseline
Change in perceived recovery
Perceived recovery will be evaluated by the Hausa Global Rating Change of Scale (GROC-H). The scale is an 11-point scale ranging from -5 to +5 with a mid-point (0) representing " no change", a left anchor (-5) representing "Very much Worse" and a right anchor (+5) representing "Completely Recovered".
Time frame: Baseline and 1 week after baseline
Change in pain Intensity
Pain Intensity will be measured by 100 mm Visual Analogue Scale (VAS-P), in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Time frame: Baseline only
Change in disability
Disability will be measured by 100 mm Visual Analogue Scale (VAS-D), in which 0 represents "no disability" and 10 represents "severe disability".
Time frame: Baseline only
Change in mobility of the spine and pelvis
The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.
Time frame: Baseline only
Plan to share: Undecided
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Ran from Jan 2018 to primary completion in Jan 2019, 12 months.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Bayero University Kano, Nigeria