Knee OsteoarthritisNCT05949489
Psychological and Pain Factors in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- WOMAC pain subscale
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 15 Jul 2024
- 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: Patients with clinical knee osteoarthritis experiencing persistent knee pain.
Who may be able to join
- Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
- Pain in or around the knee on most days of the past month
- Aged 40 years or above
- Ambulatory with or without walking aid
Who cannot join
- Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
- Recent knee injury or surgery (past 3 months)
- Severe comorbidity likely to prevent study completion (dementia, terminal illness)
- inability to comply with study procedures or follow up
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Associations Between Psychological Factors, Pain Sensitivity, and Physical Function in Knee Osteoarthritis: a One-year Follow up Study
This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- WOMAC pain subscale
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOMAC pain subscaleDiagnostic test
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale is a self-reported questionnaire that is used to measure pain in people with osteoarthritis (OA). The subscale consists of five items that ask about the intensity, frequency, and duration of pain in the hip and knee joints.
The WOMAC Pain Subscale has been shown to be a reliable and valid measure of pain in people with OA. It has been used in a number of clinical trials and is considered to be a standard measure of pain in OA.
The WOMAC Pain Subscale is scored on a scale of 0 to 4, with 0 indicating no pain and 4 indicating severe pain. The total score for the subscale is the sum of the scores for the five items. A higher score indicates more pain.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Patients with physician-diagnosed knee osteoarthritis Receives: Diagnostic Test: WOMAC pain subscale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Function from Baseline to 1 year (WOMAC)
Assessed using the WOMAC physical function subscale (0-68 scale, higher = worse function)
Measured: Change from baseline at 1 year
Secondary outcomes (4)
Pain Catastrophizing Scale
Assessed using the Pain Catastrophizing Scale (0-52 scale, higher = higher catastrophizing)
Measured: Change from baseline at 1 year
Kinesiophobia
Assessed using the Tampa Scale of Kinesiophobia (17-68 scale, higher = higher kinesiophobia)
Measured: Change from baseline at 1 year
Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)
Assessed using the Pittsburgh Sleep Quality Index (0-21 scale, higher = worse sleep quality)
Measured: Change from baseline at 1 year
Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)
Assessed using the Pain Self-Efficacy Questionnaire (0-60 scale, higher = stronger self-efficacy beliefs)
Measured: Change from baseline at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949489
- Sponsor's protocol ID
- Knee OA Study 01
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Psychological Factors, Pain Sensitivity, and Physical Function in Knee Osteoarthritis: a One-year Follow up Study
- ClinicalTrials.gov ID
- NCT05949489
- Acronym / sponsor ID
- Knee OA Study 01
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 18 Jul 2023 (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.
This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | Diagnostic Test: WOMAC pain subscalePatients with physician-diagnosed knee osteoarthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical knee osteoarthritis experiencing persistent knee pain.
Key inclusion criteria (4 listed)
- Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
- Pain in or around the knee on most days of the past month
- Aged 40 years or above
- Ambulatory with or without walking aid
Key exclusion criteria (4 listed)
- Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
- Recent knee injury or surgery (past 3 months)
- Severe comorbidity likely to prevent study completion (dementia, terminal illness)
- inability to comply with study procedures or follow up
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 |
|---|---|---|
| WOMAC pain subscaleThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale is a self-reported questionnaire that is used to measure pain in people with osteoarthritis (OA). The subscale consists of five items that ask about the intensity, frequency, and duration of pain in the hip and knee joints. The WOMAC Pain Subscale has been shown to be a reliable and valid measure of pain in people with OA. It has been used in a number of clinical trials and is considered to be a standard measure of pain in OA. The WOMAC Pain Subscale is scored on a scale of 0 to 4, with 0 indicating no pain and 4 indicating severe pain. The total score for the subscale is the sum of the scores for the five items. A higher score indicates more pain. | Diagnostic test | Knee Osteoarthritis |
Primary outcome
Change in Physical Function from Baseline to 1 year (WOMAC)
Time frame: Change from baseline at 1 year
Assessed using the WOMAC physical function subscale (0-68 scale, higher = worse function)
4 secondary outcomes
Pain Catastrophizing Scale
Time frame: Change from baseline at 1 year
Kinesiophobia
Time frame: Change from baseline at 1 year
Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)
Time frame: Change from baseline at 1 year
Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)
Time frame: Change from baseline at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian 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, run by Ahram Canadian University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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 Egypt. 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 Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function from Baseline to 1 year (WOMAC) (time frame: Change from baseline at 1 year). 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 18 Jul 2023.