Knee OsteoarthritisEARS-ArNCT04909099
Arabic Version of the EARS Questionnaire
An observational study of Knee Osteoarthritis and Low Back Pain, run by Prince Sultan Military College of Health Sciences at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Osteoarthritis, Low Back Pain
- What is being tested?
- Standard treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Feb 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- degenerative systemic diseases
- neurological symptoms
- lumbar stenosis
- spondylolisthesis
- history of spinal or knee surgeries
- pregnancy
Show all 9Show fewer
- rheumatoid arthritis
- serious pathological conditions (inflammatory arthritis and malignancy)
- individuals who cannot read and understand documents written in the Arabic language.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahd Military Medical Complex
Dhahran, Eastern Province, 31932
Ahmed Farrag, PhD, +966 546767865, ahmedfarrag@cu.edu.eg
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis, Low Back Pain
- Being tested
- Standard treatment
- Medical subject headings
- Osteoarthritis, Knee, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee Ostearthritis/ Low Bakc Pain | Patients referred for physical therapy rehabilitation Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Content Validity
Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-7 days
Secondary outcomes (1)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Feb 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military College of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahd Military Medical Complex
- Responsible party
- Principal investigator, Ahmed Farrag, Prince Sultan Military College of Health Sciences
- Investigators
- Ahmed Farrag, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909099
- Sponsor's protocol ID
- IRB-2020-PT-039
- Acronym
- EARS-Ar
- Status last verified
- Sep 2022
- First submitted
- 26 May 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 11124735Meade 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.
PubMed 29575381Terwee 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.
PubMed 17161752Newman-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.
PubMed 27913064de 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.
PubMed 32398068
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Exercise Adherence Rating Scale
- ClinicalTrials.gov ID
- NCT04909099
- Acronym / sponsor ID
- EARS-Ar / IRB-2020-PT-039
- Conditions
- Knee Osteoarthritis, Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prince Sultan Military College of Health SciencesUniversity, hospital or other
- Collaborators
- King Fahd Military Medical Complex
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to translate and cross-culturally adapt the Exercise Adherence Rating Scale (EARS) into the Arabic language, and assess its psychometric properties.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Ostearthritis/ Low Bakc Pain | – | Other: Standard treatmentPatients referred for physical therapy rehabilitation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- degenerative systemic diseases
- neurological symptoms
- lumbar stenosis
- spondylolisthesis
- history of spinal or knee surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatmentParticipants 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. | Other | Knee Ostearthritis/ Low Bakc Pain |
Primary outcome
Floor and ceiling effect
Time frame: 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
Time frame: 1 day
Assessed using the Content Validity Index (CVI) with an acceptable value of at least 0.8.
Construct Validity
Time frame: 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.
Internal Consistency
Time frame: 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
Time frame: 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.
1 secondary outcome
Responsiveness
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 29575381Meade 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.
- Background: PubMed 17161752Terwee 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.
- Background: PubMed 27913064Newman-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.
- Background: PubMed 32398068de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Farrag, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Low Back Pain, run by Prince Sultan Military College of Health Sciences at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Farrag, PhD (+966 546767865, ahmedfarrag@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Floor and ceiling effect (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909099, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.