Arabic Version of the EARS Questionnaire

NCT04909099 | Unknown

• 1 other identifier: IRB-2020-PT-039
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Low Back Pain

Outcome Measures

Primary Outcomes (5)

• 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

• 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 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 Outcomes (1)

• Responsiveness

  3 weeks

Study Arms (1)

Knee Ostearthritis/ Low Bakc Pain

Patients referred for physical therapy rehabilitation

Other: Standard treatment

Interventions

Standard treatment OTHER

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.

Knee Ostearthritis/ Low Bakc Pain

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

King Fahd Military Medical Complex

Dhahran, Eastern Province, 31932, Saudi Arabia

RECRUITING

Related 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. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• 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.

  PMID: 29575381 BACKGROUND

• 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.

  PMID: 17161752 BACKGROUND

• 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.

  PMID: 27913064 BACKGROUND

• 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.

  PMID: 32398068 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Low Back Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Farrag, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Farrag, PhD

CONTACT

+966 546767865; ahmedfarrag@cu.edu.eg

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: May 26, 2021
• First Posted: June 1, 2021
• Study Start: February 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

SA (1)