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NCT Number: NCT04648956

Arabic Version of the ICOAP 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Sultan Military College of Health Sciences

Dhahran, Eastern Province, 31932, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 Arabic language.

Treatment and study plan

standard treatment

Other

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

Primary outcomes

  1. Content Validity

    Time frame: 1 day

    Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.

  2. Construct Validity

    Time frame: 1 day

    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.

  3. Internal Consistency

    Time frame: 48-72 hours

    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.

  4. Test-retest Reliability

    Time frame: 48-72 hours

    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.

Secondary outcomes

  1. Responsiveness

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Prince Sultan Military College of Health Sciences

Other

Collaborators

  • King Fahd Military Medical Complex

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2020
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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