Clinical trial NCT03412279: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with CLBP attending either rural or urban physiotherapy clinics in Kano State, Northern Nigeria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in functional disability
timeFrame: Baseline and 1 week after baseline
measure: Change in pain intensity
timeFrame: Baseline and 1 week after baseline
measure: Change in functional disability
timeFrame: Baseline and 1 week after baseline
measure: Change in quality of life
timeFrame: Baseline and 1 week after baseline
measure: Change in fear-avoidance beliefs
timeFrame: Baseline and 1 week after baseline
measure: Change in pain catastrophization
timeFrame: Baseline and 1 week after baseline
measure: Change in back beliefs
timeFrame: Baseline and 1 week after baseline
measure: Change in perceived recovery
timeFrame: Baseline and 1 week after baseline
Secondary outcomes:
measure: Change in pain Intensity
timeFrame: Baseline only
measure: Change in disability
timeFrame: Baseline only
measure: Change in mobility of the spine and pelvis
timeFrame: Baseline only
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Murtala Muhammad Specialist Hospital, Wudil General Hospital, Rano General Hospital, Kura General Hospital, and Dawakin-Kudu General Hospital
Study officials:
References: