Arabic Version of the EARS Questionnaire

Recruiting

• Conditions: Knee Osteoarthritis; Low Back Pain
• Interventions: Other: Standard treatment

• Registration Number: NCT04909099
• Lead Sponsor: Prince Sultan Military College of Health Sciences

Brief Summary

A study to translate and cross-culturally adapt the Exercise Adherence Rating Scale (EARS) into the Arabic language, and assess its psychometric properties.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-01
• Study Start: 2022-02-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Low back pain patients: aged 18 years or older, experienced non-specific CLBP of 3 months or longer, pain localized to the lumbar region.
• Knee OA patients: eligible participants must meet the knee OA diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria

• degenerative systemic diseases
• neurological symptoms
• lumbar stenosis
• spondylolisthesis
• history of spinal or knee surgeries
• pregnancy
• rheumatoid arthritis
• serious pathological conditions (inflammatory arthritis and malignancy)
• individuals who cannot read and understand documents written in the Arabic language.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee Ostearthritis/ Low Bakc Pain	Standard treatment	Patients referred for physical therapy rehabilitation

Primary Outcome Measures

Name	Time	Method
Floor and ceiling effect	1 day	It will be considered present if more than 15% of the sample score the lowest or highest possible total score, respectively
Content Validity	1 day	Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.
Internal Consistency	3-7 days	Assessed by calculating the Cronbach's alpha (α) and the corrected item-total correlation. A Cronbach's α value of ≥0.7, and a corrected item-total correlation, measured using the Pearson correlation coefficient, of ≥0.3 will be considered acceptable.
Test-retest Reliability	3-7 days	Assessed by calculating the intraclass correlation coefficient (ICC) between the EARS-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.
Construct Validity	1 day	Assessed by calculating the Spearman's correlation coefficient (ρ) between the Exercise Adherence Rating Scale-Arabic version (EARS-Ar) score and the Fear Avoidance Belief Questionnaire (FABQ), the Numeric Pain Rating Scale (NPRS), the Roland-Morris Disability Questionnaire (RMDQ), and the Knee Injury and osteoarthritis Outcome Score (KOOS) measurement tools. The coefficient is classified as follows: ρ = 0.3-0.7 moderate correlation, and \>0.7 strong correlation.

Secondary Outcome Measures

Name	Time	Method
Responsiveness	3 weeks	Participating patients will be categorized according to their reported Global Rating of Change (GRoC) scores (external anchor) to either improved (GRoC≥3) or stable group (GRoC\<3 to \>-3) and a between-group comparison will be performed using an unpaired t-test.

Trial Locations

Locations (1)

King Fahd Military Medical Complex; 🇸🇦 Dhahran, Eastern Province, Saudi Arabia