Arabic Version of the EARS Questionnaire

Low Back Pain Clinical Trial

— EARS-Ar  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909099
• Other study ID #: IRB-2020-PT-039
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Prince Sultan Military College of Health Sciences
• Contact: Ahmed Farrag, PhD
• Phone: +966 546767865
• Email: ahmedfarrag[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Low Back Pain
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Fahd Military Medical Complex	Dhahran	Eastern Province

Sponsors (2)

Lead Sponsor	Collaborator
Prince Sultan Military College of Health Sciences	King Fahd Military Medical Complex

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (5)

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. Review. — View Citation

de Lira MR, de Oliveira AS, França 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Content Validity	Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.	1 day
Primary	Construct Validity	Assessed by calculating the Spearman's correlation coefficient (?) 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: ? = 0.3-0.7 moderate correlation, and >0.7 strong correlation.	1 day
Primary	Internal Consistency	Assessed by calculating the Cronbach's alpha (a) and the corrected item-total correlation. A Cronbach's a 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
Primary	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	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