OsteoarthritisNCT04956510
Osteoarthritis in Terms of ICF Components
An observational study of Osteoarthritis and Quality of Life, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Quality of Life, OUTCOME MEASURES
- What is being tested?
- Evaluation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Apr 2020
- How long will I take part?
- 3 Months
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-seven patients with OA were included in this study, who met inclusion criteria and were diagnosed with OA by the same rheumatologist according to the American College of Rheumatology Clinical Classification Criteria for OA.
Who may be able to join
- diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;[14,15]
- being in the age range 18-65; and
- absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).
Who cannot join
- comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
- previous lower extremity surgery;
- Intra-articular steroid or hyaluronic acid injection in the last three months
- cognitive impairments;
- pregnancy; and
- illiteracy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University School of Physical Therapy and Rehabilitation
Denizli
About this study
Official title: Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life
Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.
- Conditions
- Osteoarthritis, Quality of Life, OUTCOME MEASURES
- Being tested
- Evaluation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
health status and quality of life were evaluated
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities (WOMAC) OA Index:
The WOMAC Index is a self-administered, disease-specific questionnaire consisting of 24 items which are widely used in the evaluation of hip and knee OA. It consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). High score indicates worse pain, stiffness, and functional limitations.
Measured: 15 min
Nottingham Health Profile (NHP):
NHP is a widely used measure of perceived distress of patients in physical, emotional and social domains. It consists of 38 items which are physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Questions have "yes" or "no" answers. Higher score indicates greater distress
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Nov 2019
- Primary completion10 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gur Kabul, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956510
- Sponsor's protocol ID
- PAU
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life
- ClinicalTrials.gov ID
- NCT04956510
- Acronym / sponsor ID
- PAU
- Conditions
- Osteoarthritis, Quality of Life, OUTCOME MEASURES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 9 Jul 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.
Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-seven patients with OA were included in this study, who met inclusion criteria and were diagnosed with OA by the same rheumatologist according to the American College of Rheumatology Clinical Classification Criteria for OA.
Key inclusion criteria (3 listed)
- diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;[14,15]
- being in the age range 18-65; and
- absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).
Key exclusion criteria (6 listed)
- comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
- previous lower extremity surgery;
- Intra-articular steroid or hyaluronic acid injection in the last three months
- cognitive impairments;
- pregnancy; and
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 |
|---|---|---|
| Evaluationhealth status and quality of life were evaluated | Other | – |
Primary outcome
The Western Ontario and McMaster Universities (WOMAC) OA Index:
Time frame: 15 min
The WOMAC Index is a self-administered, disease-specific questionnaire consisting of 24 items which are widely used in the evaluation of hip and knee OA. It consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). High score indicates worse pain, stiffness, and functional limitations.
Nottingham Health Profile (NHP):
Time frame: 15 min
NHP is a widely used measure of perceived distress of patients in physical, emotional and social domains. It consists of 38 items which are physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Questions have "yes" or "no" answers. Higher score indicates greater distress
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 9 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis and Quality of Life, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 9 Jul 2021. 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 Turkey (Türkiye). 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?
The Western Ontario and McMaster Universities (WOMAC) OA Index: (time frame: 15 min). The study lists 2 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 9 Jul 2021.