Translation of Neck Disability Index Into Local Pakistani Languages of Pakistan
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| ClinicalTrials.gov Identifier: NCT04843241 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2021
Last Update Posted : April 19, 2021
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| Condition or disease |
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| Neck Pain |
The Neck Disability Index is a state-unambiguous instrument for the description of a disability. It is revised from the Oswestry Low Back Pain Questionnaire It contains 10 items mentioning various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 conceivable answers for each item. Patients are educated to choose only one answer which most closely suits their condition at the current time. The score of each item ranges between 0 (no pain and no functional limitation) and 5 (worst pain and maximal limitation) that lead to the total score of 0 (no disability) to 50 (totally disabled), as 0-4 points (no disability), 5-14 points (10-28% disability), 15-24 points (30-48% disability), 25-34 points (50-64% disability) and 35-50 points (70-100% disability). The meantime to fill the questionnaire is 3-7.8 minutes. The NDI showed high validity and reliability for patients with neck pain.
By this study, the accuracy and reproducibility of the translated versions of NDI questionnaires will be enhanced and thus can create a useful measure to obtain data from culturally/linguistically diverse people belonging to different ethnic background as in Pakistan. It will create trustworthiness among clinicians and researchers to utilize the tool as a measure of what it is supposed to measure.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | Test of Reliability and Validation of Neck Disability Index Questionnaire in Local Languages of Pakistan |
| Actual Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
- Translation of the Neck Disability Index questionnaire into Pushto, Punjabi, Sindhi and Balochi versions [ Time Frame: 6 months ]The Neck Disability Index is a state-unambiguous instrument for the description of a disability. It is revised from the Oswestry Low Back Pain Questionnaire It contains 10 items mentioning various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 conceivable answers for each item, so translation for this NDI is to be done into regional languages of Pakistan through a rigorous and approved process. The minimum and maximum possible scores could be 0 and 50. The higher the score more the disability is there.
- Test the validity & reliability of translated versions of Neck Disability Index among neck pain patients in Pakistan [ Time Frame: 6 months ]To determine reliability and validity of cross-culturally adapted and the translated NDI versions in patients with neck pain of respective languages۔ Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient and validity is how accurate the results are. Thus these both are to measured through various parameters to validate the translated versions as appropriate and applicable.
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| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Mechanical neck pain
- Participants belonging to Urdu, Pushto, Punjabi, Sindhi and Balochi speaking class
- Participants from inpatient and outpatient department of hospitals
- participants should complete the questionnaire in their respective language without the help
Exclusion Criteria:
- Healthy Individuals
- Pathological neck pain
- Traumatic cervical or neck injuries
- Participants with disability due to any structural/ congenital cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843241
| Contact: Imran Amjad, PhD | 03324390125 | imran.amjad@riphah.edu.pk | |
| Contact: Syed Hashir Ali, MSPT(SPT) |
| Pakistan | |
| Margalla Rehabilitation Center | Recruiting |
| Rawalpindi, Punjab, Pakistan | |
| Contact: Nazim Farooq, Phd 03004269864 nazimfarooq@yahoo.com | |
| Principal Investigator: Syed Hashir Ali, MS | |
| Principal Investigator: | Imran Amjad, PhD | Riphah International University |
| Responsible Party: | Riphah International University |
| ClinicalTrials.gov Identifier: | NCT04843241 |
| Other Study ID Numbers: |
REC/00934 Syed Hashir Ali |
| First Posted: | April 13, 2021 Key Record Dates |
| Last Update Posted: | April 19, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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