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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2019
Source Bayero University Kano, Nigeria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Application of the initial evaluation
Initial evaluation involves the application of Hausa ODI, NPRS, RMDQ, SF-12, PCS, GROC, BBQ, VAS for pain and disability, and FFD.
Final application of instruments
Application of the Hausa versions of ODI, NPRS, RMDQ, SF-12, PCS, GROC and BBQ one week after initial evaluation

Locations

Country Name City State
Nigeria Murtala Muhammad Specialist Hospital, Wudil General Hospital, Rano General Hospital, Kura General Hospital, and Dawakin-Kudu General Hospital Kano

Sponsors (1)

Lead Sponsor Collaborator
Bayero University Kano, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

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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