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Clinical Trials/NCT03412279
NCT03412279
Completed
Not Applicable

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

Bayero University Kano, Nigeria1 site in 1 country200 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Bayero University Kano, Nigeria
Enrollment
200
Locations
1
Primary Endpoint
Change in fear-avoidance beliefs
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
January 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayero University Kano, Nigeria
Responsible Party
Principal Investigator
Principal Investigator

Aminu A. Ibrahim

Principal Investigator

Bayero University Kano, Nigeria

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

Outcomes

Primary Outcomes

Change in fear-avoidance beliefs

Time Frame: Baseline and 1 week after baseline

Fear-avoidance beliefs will be measured by the Hausa fear avoidance beliefs

Change in back beliefs

Time Frame: Baseline and 1 week after baseline

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.

Change in perceived recovery

Time Frame: Baseline and 1 week after baseline

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".

Change in functional disability

Time Frame: Baseline and 1 week after baseline

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.

Change in pain intensity

Time Frame: Baseline and 1 week after baseline

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".

Change in quality of life

Time Frame: Baseline and 1 week after baseline

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.

Change in pain catastrophization

Time Frame: Baseline and 1 week after baseline

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.

Secondary Outcomes

  • Change in pain Intensity(Baseline only)
  • Change in mobility of the spine and pelvis(Baseline only)
  • Change in disability(Baseline only)

Study Sites (1)

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