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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04843241
Other study ID # REC/00934 Syed Hashir Ali
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 30, 2021

Study information

Verified date April 2021
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to translate the neck disability index (NDI) questionnaire into Pushto, Punjabi, Sindhi and Balochi versions and o test the validity & reliability of translated versions of NDI among neck pain patients in Pakistan.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Margalla Rehabilitation Center Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. — View Citation

Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5. — View Citation

Howell ER. The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review. J Can Chiropr Assoc. 2011 Sep;55(3):211-21. — View Citation

Rathore FA, Attique R, Asmaa Y. Prevalence and Perceptions of Musculoskeletal Disorders Among Hospital Nurses in Pakistan: A Cross-sectional Survey. Cureus. 2017 Jan 26;9(1):e1001. doi: 10.7759/cureus.1001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Translation of the Neck Disability Index questionnaire into Pushto, Punjabi, Sindhi and Balochi versions 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. 6 months
Secondary Test the validity & reliability of translated versions of Neck Disability Index among neck pain patients in Pakistan 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. 6 months
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