Chronic Low Back Pain Clinical Trial
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
NCT number | NCT03412279 |
Other study ID # | PPT/00009 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | January 31, 2019 |
Verified date | June 2019 |
Source | Bayero University Kano, Nigeria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | Murtala Muhammad Specialist Hospital, Wudil General Hospital, Rano General Hospital, Kura General Hospital, and Dawakin-Kudu General Hospital | Kano |
Lead Sponsor | Collaborator |
---|---|
Bayero University Kano, Nigeria |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 1 week after baseline | |
Primary | 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". | Baseline and 1 week after baseline | |
Primary | 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. | Baseline and 1 week after baseline | |
Primary | 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. | Baseline and 1 week after baseline | |
Primary | Change in fear-avoidance beliefs | Fear-avoidance beliefs will be measured by the Hausa fear avoidance beliefs | Baseline and 1 week after baseline | |
Primary | 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. | Baseline and 1 week after baseline | |
Primary | 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. | Baseline and 1 week after baseline | |
Primary | 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". | Baseline and 1 week after baseline | |
Secondary | 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". | Baseline only | |
Secondary | 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". | Baseline only | |
Secondary | 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. | Baseline only |
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