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

NCT03412279 | Completed

• 1 other identifier: PPT/00009
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• Change in fear-avoidance beliefs

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

  Baseline and 1 week after baseline

• 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

• 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

• 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 Outcomes (3)

• Change in pain Intensity

  Baseline only

• Change in disability

  Baseline only

• Change in mobility of the spine and pelvis

  Baseline only

Interventions

Application of the initial evaluation BEHAVIORAL

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 BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with CLBP attending either rural or urban physiotherapy clinics in Kano State, Northern Nigeria.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead

Study Sites (1)

Murtala Muhammad Specialist Hospital, Wudil General Hospital, Rano General Hospital, Kura General Hospital, and Dawakin-Kudu General Hospital

Kano, 700, Nigeria

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

NG (1)