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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05429931
Other study ID # REC/FSD/0296
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 12, 2022

Study information

Verified date June 2022
Source Riphah International University
Contact Muhammad Kashif
Phone +92418777210
Email kashif.shaffi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale.


Description:

The Ronald Morris Disability Questionnaire will be translated into Urdu and culturally adapted for people with low back pain. Ronald Morris Disability Questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. Method of sampling based on pre-determined inclusion and exclusion criteria. To examine intra-observer reliability of the final Ronald Morris Disability Questionnaire, two observers will fill out Oswestry Disability Index and Visual Analogue Scale questionnaires on the same day to test inter-observer evaluation. After 30 minutes of the initial treatment, the second application will be applied. The first observer will do the third assessment after seven days. Statistical Package of Social Sciences Version 24 will be used to enter and analyse data. The alpha value of Cronbach's alpha will be examined.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 12, 2022
Est. primary completion date July 10, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Average Age of patient 48 years. - Patient with chronic low back pain have at least 3 month duration . - Patient with mechanical Low Back Pain Exclusion Criteria: - Patient with non - mechanical Low Back Pain - Patient have neurological deficits .

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 Roland-Morris Disability Questionnaire Roland-Morris Disability Questionnaire consist of 24 point according to low back pain population in which patients tell about all Daily Activity . patients scores the questionnaire among 24 points. Roland-Morris Disability Questionnaire is the highest result possible '24'. 1st day
Primary Oswestry Disability Index Oswestry Disability Index is an instrument or scale use for the evaluation of pain . this scale is especially designed for low back pain.
Oswestry Disability Index consist of 10 section or 9 section divide the point out of 50 or 45 . if one section is not score then divided by 45 and get score of patient.after get score multiply with 100 to get percentage. 0 to 21% indicate minimal disability , 21 to 40 indicate moderate disability and 41 to 60 indicate severe disability. 61 to 80 indicate crippled.
1st day
Primary Visual Analogue Scale Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". 1st day
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