Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000244707
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
10/02/2022
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability and Validity of The Urdu Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire
Scientific title
Reliability and Validity of The Urdu Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire for Patients with Knee and Hip Osteoarthritis
Secondary ID [1] 304099 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 321753 0
Knee Osteoarthritis 321754 0
Condition category
Condition code
Musculoskeletal 319494 319494 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completion of ICOAP-U and Global Rating of Change Scale questionnaire taking approximately 20 to 30 minutes. The number of times and frequency with which participants with knee and hip osteoarthritis will complete the questionnaire at 1 day 2 days and 2 weeks post-enrolment. participants will attend a face-to-face session to complete the questionnaires
Intervention code [1] 320419 0
Not applicable
Comparator / control treatment
Participants with Knee osteoarthritis will complete the KOOS and with hip osteoarthritis HOOS will each take approximately 15 minutes to complete and participants will attend a face-to-face session to complete the questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 327366 0
Content Validity Index of the ICOAP-U assessed by a panel of experts, with a value of at least 0.8 considered to have excellent content validity.
Timepoint [1] 327366 0
Immediately post-completion of ICOAP-U on day 1 post-enrolment.
Primary outcome [2] 327367 0
Construct validity of ICOAP-U will be assessed using a factor analysis.
Timepoint [2] 327367 0
Immediately post-completion of ICOAP-U on day 1 post-enrolment
Primary outcome [3] 327368 0
The internal consistency of the ICOAP-U will be assessed by calculating the Cronbach alpha (a) and the corrected total object correlation. A Cronbach a value of equal to 0.7 and a corrected total item correlation, measured using the Pearson correlation coefficient equal to 0.3 are considered acceptable.
Timepoint [3] 327368 0
Comparison between ICOAP-U completed at 48 and 72 hours post-enrolment
Secondary outcome [1] 394817 0
Test-retest reliability will be evaluated by calculation of intraclass correlation coefficients (ICC) between the ICOAP-Ur-scores of the first two test sessions. An ICC value of> 0.8 and 0.6 to 0.8 is regarded as an excellent or good correlation.
Timepoint [1] 394817 0
Comparison between ICOAP-U completed at 48 and 72 hours post-enrolment

Eligibility
Key inclusion criteria
Inclusion Criteria: Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
rheumatoid arthritis
serious pathological conditions (inflammatory arthritis and malignancy)
total or partial arthroplasty of the affected joint
individuals who cannot read and understand documents written in the Urdu language.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
15/03/2022
Actual
Sample size
Target
110
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 23657 0
Pakistan
State/province [1] 23657 0

Funding & Sponsors
Funding source category [1] 308470 0
Self funded/Unfunded
Name [1] 308470 0
Muhammad Kashif
Country [1] 308470 0
Pakistan
Primary sponsor type
University
Name
Riphah International University
Address
Riphah College of Rehabilitation and Allied Health Sciences
Riphah International University,
Satiana Road Faisalabad Pakistan
Post Code 3800
Country
Pakistan
Secondary sponsor category [1] 309311 0
None
Name [1] 309311 0
Address [1] 309311 0
Country [1] 309311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308426 0
Research and Ethics Committee ,Riphah College of Rehabilitation Sciences, Riphah International University, Pakistan.
Ethics committee address [1] 308426 0
Ethics committee country [1] 308426 0
Pakistan
Date submitted for ethics approval [1] 308426 0
15/02/2021
Approval date [1] 308426 0
18/03/2021
Ethics approval number [1] 308426 0
RCRAHS/REC/FSD/00285

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110666 0
A/Prof Muhammad Kashif
Address 110666 0
Riphah College of Rehabilitation and Allied Health Sciences Riphah International University Satiana Road, Faisalabad Pakistan Post Code 3800
Country 110666 0
Pakistan
Phone 110666 0
+923333125303
Fax 110666 0
Email 110666 0
[email protected]
Contact person for public queries
Name 110667 0
Muhammad Kashif
Address 110667 0
Riphah College of Rehabilitation and Allied Health Sciences Riphah International University Satiana Road, Faisalabad Pakistan Post Code 3800
Country 110667 0
Pakistan
Phone 110667 0
+923333125303
Fax 110667 0
Email 110667 0
[email protected]
Contact person for scientific queries
Name 110668 0
Muhammad Kashif
Address 110668 0
Riphah College of Rehabilitation and Allied Health Sciences Riphah International University Satiana Road, Faisalabad Pakistan Post Code 3800
Country 110668 0
Pakistan
Phone 110668 0
+923333125303
Fax 110668 0
Email 110668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal and at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Mataanalysis

When can requests for individual participant data be made (start and end dates)?
From:
6 months following publication of main results; no end-date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Contacting Principal Investigator Dr Muhammad Kashif

Riphah International University
Satiana Road Faisalabad
Email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11537Ethical approval  [email protected] Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.