Arabic Version of the ICOAP Questionnaire

NCT04648956 | Completed

• 1 other identifier: IRB-2020-PT-031
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Keywords

ICOAP questionnaire; Arabic; Cross-Cultural adaptation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Responsiveness

  4 weeks

Study Arms (1)

Knee/Hip osteoarthritis

Patients referred for physical therapy rehabilitation

Other: Standard treatment

Interventions

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.

Also known as: ICOAP questionnaire

Knee/Hip osteoarthritis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sultan Military College of Health Sciences: lead
• King Fahd Military Medical Complex: collaborator

Study Sites (1)

Prince Sultan Military College of Health Sciences

Dhahran, Eastern Province, 31932, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ahmed Farrag, PhD

  Prince Sultan Military College of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 2, 2020
• Study Start: October 25, 2020
• Primary Completion: March 30, 2022
• Study Completion: April 15, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

SA (1)