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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05221073
Other study ID # REC/FSD/0288
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date February 28, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of study is to translate & culturally adapt Neck Bournemouth Questionnaire into Urdu language along with investigation of the reliability & validity of Neck Bournemouth Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index, Visual Analogue Scale, Neck Pain and Disability Scale and Rand 36-Item Health Survey


Description:

The English version of the Bournemouth Questionnaire for Neck Pain will be translated and culturally adapted as per as previous recommendations. In the general population with neck pain, Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be distributed among participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. Test inter and intra- observer reliability of the final Urdu Version Of The Bournemouth Questionnaire For Neck Pain with Neck Disability Index, Neck Pain and Disability Scale, Visual Analogue Scale, and RAND will be filled with same day, by two observers and for the inter-observers assessment, with an interval of 45 minutes between the first and second application. Third assessment will be carried out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value. Test -retest reliability will be assessed using interclass correlation coefficient. The Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be evaluated for content validity, construct validity, criterion validity and responsiveness.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date February 28, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18 to 65 years of age - 3 months of neck pain - Neck pain more than six moth - Male female both genders - Physician referral - Not prescribed medicine - Without deformity in neck - Ability of reading and writing Exclusion Criteria: - Joint inflammation or infection - Pathology of shoulder - Fibromylgia - Psychologically unstable or having neurological disorder - Cancer history - Cervical injury - Took treatment of physical therapy in last 6 month - Any disability - Loss of memory - Disease or any Red flag - Using Neck immobilization device

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck Bournemouth Questionnaire Neck Bournemouth Questionnaire contain seven dimensions tool used for the investigation of pain,functional ability, activity, depression,anxiety, work avoidance due to fear and control of pain 1st day
Primary Neck Disability Index The Neck Disability Index is most frequently used to evaluate pain in neck and neck pain related disability. One of previous study stated that the Neck Disability Index having multidisciplinary approach to disability 1st day
Primary Visual Analogue Scale Visual Analogue Scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the symptom to be evaluated. The line is usually 10 cm long and vertical, though different lengths and orientations have been employed and proven satisfactory. 1st day
Primary Neck Pain and Disability Scale The 20 items in the Neck Pain and Disability Scale measure the intensity of pain,its interference with the vocational,recreational,social, and functional aspects of living,and the presence and extent of associated emotional factors. The Neck Pain and Disability Scale is intended to be worded clearly and easy to complete. 1st day
Primary Rand 36-Item Health Survey Scoring the Rand 36-Item Health Survey 1.0 is a two-step process. First, preceded numeric values are recorded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. 1st day
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