Knee OsteoarthritisNCT04648956
Arabic Version of the ICOAP Questionnaire
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, 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 Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Standard treatment
- How many people
- 99 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Oct 2020to 15 Apr 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.
Who may be able to join
- Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).
Who cannot join
- rheumatoid arthritis
- serious pathological conditions (inflammatory arthritis and malignancy)
- total or partial arthroplasty of the affected joint
- individuals who cannot read and understand documents written in the Arabic language.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sultan Military College of Health Sciences
Dhahran, Eastern Province, 31932
About this study
Official title: Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Intermittent and Constant Osteoarthritis Pain Questionnaire
A study to translate and cross-culturally adapt the Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Standard treatment
- Keywords
- ICOAP questionnaire, Arabic, Cross-Cultural adaptation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentOther
Also called ICOAP questionnaire
Participants shall fill the ICOAP-Ar questionnaire three times within one month in addition to other questionnaires including the KOOS/HOOS, and the Global Rating of Change Scale (GRoC). The first two times will be within a time frame of 48-72 hours. The third time will be after one month.
| Study group | Role | What they receive |
|---|---|---|
| Knee/Hip osteoarthritis | 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.
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 Arabic ICOAP (ICOAP-Ar) score and the relevant pain and symptoms score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) 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 corrected item-total correlation, measured using the Pearson correlation coefficient, of ≥0.3 will be considered acceptable.
Measured: 48-72 hours
Test-retest Reliability
Assessed by calculating the intraclass correlation coefficient (ICC) between the ICOAP-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: 48-72 hours
Secondary outcomes (1)
Responsiveness
Participants will be categorized according to their reported Global Rating of Change (GRoC) Scale scores to either improved (GRoC ≥3) or stable group (GRoC <3 to >-3) and between-group comparison of each group's ICOAP-Ar scores will be performed using unpaired t-test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start25 Oct 2020
- Primary completion30 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 99 participants (actual)
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, Prince Sultan Military College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648956
- Sponsor's protocol ID
- IRB-2020-PT-031
- Status last verified
- Sep 2022
- First submitted
- 18 Nov 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 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 Intermittent and Constant Osteoarthritis Pain Questionnaire
- ClinicalTrials.gov ID
- NCT04648956
- Acronym / sponsor ID
- IRB-2020-PT-031
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Keywords
- ICOAP questionnaire, Arabic, Cross-Cultural adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Prince Sultan Military College of Health SciencesUniversity, hospital or other
- Collaborators
- King Fahd Military Medical Complex
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 2 Dec 2020 (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 Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool 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/Hip osteoarthritis | – | Other: Standard treatmentPatients referred for physical therapy rehabilitation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knee/Hip osteoarthritis patients recruited from the local community receiving physical therapy rehabilitation.
Key inclusion criteria (1 listed)
- Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).
Key exclusion criteria (4 listed)
- rheumatoid arthritis
- serious pathological conditions (inflammatory arthritis and malignancy)
- total or partial arthroplasty of the affected joint
- individuals who cannot read and understand documents written in the Arabic language.
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 treatmentAlso: ICOAP questionnaireParticipants shall fill the ICOAP-Ar questionnaire three times within one month in addition to other questionnaires including the KOOS/HOOS, and the Global Rating of Change Scale (GRoC). The first two times will be within a time frame of 48-72 hours. The third time will be after one month. | Other | Knee/Hip osteoarthritis |
Primary outcome
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 Arabic ICOAP (ICOAP-Ar) score and the relevant pain and symptoms score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Hip Injury and Osteoarthritis Outcome Score (HOOS) measurement tools. The coefficient is classified as follows: ρ = 0.3-0.7 moderate correlation, and >0.7 strong correlation.
Internal Consistency
Time frame: 48-72 hours
Assessed by calculating the Cronbach's alpha (α) and the corrected item-total correlation. A Cronbach's α value of ≥0.7, and corrected item-total correlation, measured using the Pearson correlation coefficient, of ≥0.3 will be considered acceptable.
Test-retest Reliability
Time frame: 48-72 hours
Assessed by calculating the intraclass correlation coefficient (ICC) between the ICOAP-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: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
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
Prince Sultan Military College of Health Sciences
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 Hip Osteoarthritis, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content Validity (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2022.