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Arabic Version of the ICOAP Questionnaire

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ClinicalTrials.gov Identifier: NCT04648956
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : August 24, 2021
Sponsor:
Collaborator:
King Fahd Military Medical Complex
Information provided by (Responsible Party):
Ahmed Farrag, Prince Sultan Military College of Health Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Knee Osteoarthritis Hip Osteoarthritis Other: Standard treatment

Study Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire
Actual Study Start Date : October 25, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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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 Name: ICOAP questionnaire


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648956


Contacts
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Contact: Ahmed Farrag, PhD +966 38440000 ext 6941 afarrag@psmchs.edu.sa

Locations
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Saudi Arabia
Prince Sultan Military College of Health Sciences Recruiting
Dhahran, Eastern Province, Saudi Arabia, 31932
Contact: Ahmed Farrag, PhD    +966 38440000 ext 6941    afarrag@psmchs.edu.sa   
Sponsors and Collaborators
Prince Sultan Military College of Health Sciences
King Fahd Military Medical Complex
Investigators
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Principal Investigator: Ahmed Farrag, PhD Prince Sultan Military College of Health Sciences
More Information
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Responsible Party: Ahmed Farrag, Assisstant Professor, Prince Sultan Military College of Health Sciences
ClinicalTrials.gov Identifier: NCT04648956    
Other Study ID Numbers: IRB-2020-PT-031
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Farrag, Prince Sultan Military College of Health Sciences:
ICOAP questionnaire
Arabic
Cross-Cultural adaptation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases