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Validation of Hausa Oswestry Disability Index, Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire,Global Rating of Change Scale and Back Beliefs Questionnaire in Low Back Pain Patients

Translation, Cross-cultural Adaptation, and Psychometric Properties of the Hausa Versions of the Oswestry Disability Index, Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire, Global Rating of Change Scale and Back Beliefs Questionnaire in Patients With Low Back Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03412279
Enrollment
200
Registered
2018-01-26
Start date
2018-01-01
Completion date
2019-01-31
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain, Oswestry Disability Index, Numeric Pain Rating Scale, Roland Morris Disability Questionnaire, SF-12 Health Survey, Fear-Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Global Rating of Change Scale, Back Beliefs Questionnaire

Brief summary

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.

Detailed description

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.

Interventions

Initial evaluation involves the application of Hausa ODI, NPRS, RMDQ, SF-12, PCS, GROC, BBQ, VAS for pain and disability, and FFD.

BEHAVIORALFinal application of instruments

Application of the Hausa versions of ODI, NPRS, RMDQ, SF-12, PCS, GROC and BBQ one week after initial evaluation

Sponsors

Bayero University Kano, Nigeria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Male and female between 18 and 70 years old. * Nonspecific low back pain lasting for more than 12 weeks. * Resident in the selected rural and urban communities in Kano State Nigeria. * Ability to read/understand English or Hausa language.

Exclusion criteria

* Previous history of back surgery. * Spine pathology (e.g. tumor, infection, fracture) * Severe cognitive impairment * Impaired capacity to be interviewed * Current pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived recoveryBaseline and 1 week after baselinePerceived 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.
Change in fear-avoidance beliefsBaseline and 1 week after baselineFear-avoidance beliefs will be measured by the Hausa fear avoidance beliefs
Change in pain catastrophizationBaseline and 1 week after baselinePain 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.
Change in back beliefsBaseline and 1 week after baselineBack 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.
Change in functional disabilityBaseline and 1 week after baselineFunctional 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.
Change in pain intensityBaseline and 1 week after baselinePain 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.
Change in quality of lifeBaseline and 1 week after baselineQuality 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.

Secondary

MeasureTime frameDescription
Change in disabilityBaseline onlyDisability will be measured by 100 mm Visual Analogue Scale (VAS-D), in which 0 represents no disability and 10 represents severe disability.
Change in mobility of the spine and pelvisBaseline onlyThe finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.
Change in pain IntensityBaseline onlyPain Intensity will be measured by 100 mm Visual Analogue Scale (VAS-P), in which 0 represents no pain and 10 represents worst pain imaginable.

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026