Arabic Version of the ICOAP Questionnaire

Knee Osteoarthritis Clinical Trial

Official title:

Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648956
• Other study ID #: IRB-2020-PT-031
• Status: Completed
• Start date: October 25, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: September 2022
• Source: Prince Sultan Military College of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study to translate and cross-culturally adapt the Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 15, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria:

1. rheumatoid arthritis

2. serious pathological conditions (inflammatory arthritis and malignancy)

3. total or partial arthroplasty of the affected joint

4. individuals who cannot read and understand documents written in the Arabic language.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• Standard treatment
Participants shall fill the ICOAP-Ar questionnaire three times within one month in addition to other questionnaires including the KOOS/HOOS, and the Global Rating of Change Scale (GRoC). The first two times will be within a time frame of 48-72 hours. The third time will be after one month.

Locations

Country	Name	City	State
Saudi Arabia	Prince Sultan Military College of Health Sciences	Dhahran	Eastern Province

Sponsors (2)

Lead Sponsor	Collaborator
Prince Sultan Military College of Health Sciences	King Fahd Military Medical Complex

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Content Validity	Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.	1 day
Primary	Construct Validity	Assessed by calculating the Spearman's correlation coefficient (?) between the Arabic ICOAP (ICOAP-Ar) score and the relevant pain and symptoms score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) measurement tools. The coefficient is classified as follows: ? = 0.3-0.7 moderate correlation, and >0.7 strong correlation.	1 day
Primary	Internal Consistency	Assessed by calculating the Cronbach's alpha (a) and the corrected item-total correlation. A Cronbach's a value of =0.7, and corrected item-total correlation, measured using the Pearson correlation coefficient, of =0.3 will be considered acceptable.	48-72 hours
Primary	Test-retest Reliability	Assessed by calculating the intraclass correlation coefficient (ICC) between the ICOAP-Ar scores of the first two test sessions. An ICC value of >0.8, and 0.6-0.8 will be considered as excellent and good correlation, respectively.	48-72 hours
Secondary	Responsiveness	Participants will be categorized according to their reported Global Rating of Change (GRoC) Scale scores to either improved (GRoC =3) or stable group (GRoC <3 to >-3) and between-group comparison of each group's ICOAP-Ar scores will be performed using unpaired t-test.	4 weeks