Arabic Version of the EARS Questionnaire (EARS-Ar)

Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Exercise Adherence Rating Scale

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Knee Osteoarthritis
• Intervention / Treatment: Other: Standard treatment

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Ahmed Farrag, PhD; Phone Number: +966 546767865; Email: ahmedfarrag@cu.edu.eg

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dhahran, Eastern Province, Saudi Arabia, 31932
      • Recruiting
      • King Fahd Military Medical Complex
      • Contact: Ahmed Farrag, PhD; Phone Number: +966 546767865; Email: ahmedfarrag@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be recruited from patients with chronic low back pain (CLBP) or knee osteoarthritis referred to the outpatient physical therapy services of the local medical facilities.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Knee Ostearthritis/ Low Bakc Pain; Patients referred for physical therapy rehabilitation

Other: Standard treatment; Participants shall fill the EARS-Ar questionnaire three times within one month in addition to other questionnaires including the Roland Morris Disability Questionnaire (RMDQ) for low back pain (LBP) patients, and the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA patients, in addition to the Fear-Avoidance Beliefs Questionnaire (FABQ), the Numeric Pain Rating Scale (NPRS), and the Global Rating of Change Scale (GRoC). The first time will be one week after enrolling in the study and receiving the prescribed home exercise program. the second time will be 3-6 days later to test the reliability of the EARS-Ar. After another week, participants will refill the EARS-Ar and the GRoC to test responsiveness.

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
Floor and ceiling effect	It will be considered present if more than 15% of the sample score the lowest or highest possible total score, respectively	1 day
Construct Validity	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.	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 a corrected item-total correlation, measured using the Pearson correlation coefficient, of ≥0.3 will be considered acceptable.	3-7 days
Test-retest Reliability	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.	3-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responsiveness	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.	3 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
• Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.
• Meade LB, Bearne LM, Godfrey EL. Comprehension and face validity of the Exercise Adherence Rating Scale in patients with persistent musculoskeletal pain. Musculoskeletal Care. 2018 Sep;16(3):409-412. doi: 10.1002/msc.1240. Epub 2018 Mar 25. No abstract available.
• de Lira MR, de Oliveira AS, Franca RA, Pereira AC, Godfrey EL, Chaves TC. The Brazilian Portuguese version of the Exercise Adherence Rating Scale (EARS-Br) showed acceptable reliability, validity and responsiveness in chronic low back pain. BMC Musculoskelet Disord. 2020 May 12;21(1):294. doi: 10.1186/s12891-020-03308-z.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Back Pain; Low Back Pain; Osteoarthritis, Knee
• Other Study ID Numbers: IRB-2020-PT-039

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