Arabic Version of the ICOAP Questionnaire

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Other: Standard treatment

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dhahran, Eastern Province, Saudi Arabia, 31932
      • Prince Sultan Military College of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee/Hip osteoarthritis; Patients referred for physical therapy rehabilitation	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.; Other Names: ICOAP questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content Validity	Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.	1 day
Construct Validity	Assessed by calculating the Spearman's correlation coefficient (ρ) 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: ρ = 0.3-0.7 moderate correlation, and >0.7 strong correlation.	1 day
Internal Consistency	Assessed by calculating the Cronbach's alpha (α) and the corrected item-total correlation. A Cronbach's α 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prince Sultan Military College of Health Sciences
• Collaborators: King Fahd Military Medical Complex
• Investigators: Principal Investigator: Ahmed Farrag, PhD, Prince Sultan Military College of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Arabic; ICOAP questionnaire; Cross-Cultural adaptation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: IRB-2020-PT-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No