OsteoarthritisNCT06015412
Physical Parameters in Osteoarthritis Stages
An observational study of Osteoarthritis and Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Pain, Quality of Life
- What is being tested?
- Radiographic classification
- How many people
- 161 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Jul 2023
- 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: diagnosed with the same grade of knee OA in both knees by the responsible physician in the hospital
Who may be able to join
- having the same OA grade in both knees
- volunteering to participate in the study
- not having undergone previous lower extremity surgery
Who cannot join
- neurological disorders;
- those with a history of surgery related to the lower extremities;
- those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis;
- those who had neurological, orthopedic, or cognitive disorders that would prevent walking;
- those with a diagnosis of diabetes, obesity, or rheumatological disorders;
- those who had received intra-articular injection therapy within the last three months;
- and those with malignancy or perception problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life
To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.
- Conditions
- Osteoarthritis, Pain, Quality of Life
- Being tested
- Radiographic classification
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic classificationDiagnostic test
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
| Study group | Role | What they receive |
|---|---|---|
| Grade 1 osteoarthritis | disease stages 1 according to the Kellgren-Lawrence radiographic classification system Receives: Diagnostic Test: Radiographic classification | |
| Grade 2 osteoarthritis | disease stages 2 according to the Kellgren-Lawrence radiographic classification system Receives: Diagnostic Test: Radiographic classification | |
| Grade 3 osteoarthritis | disease stages 3 according to the Kellgren-Lawrence radiographic classification system Receives: Diagnostic Test: Radiographic classification | |
| Grade 4 osteoarthritis | disease stages 4 according to the Kellgren-Lawrence radiographic classification system Receives: Diagnostic Test: Radiographic classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
a 10-cm straight line with 0 on one end indicating no pain and 10 on the other end signifying unbearable pain. The participants were asked to mark the intensity of their current pain on the line
Measured: 2 minutes
two-minute walk test (2MWT)
A 45-meter corridor was used for the 2MWT. The start and end points were marked, and the participants were asked to walk at a normal pace within these boundaries. The distance covered in two minutes was recorded
Measured: 2 minutes
Western Ontario and McMaster Universities Osteoarthritis Index
The questionnaire consists of 24 items, each scored from 0 to 4. The total score is obtained by summing the point equivalents of the responses given to all items. A higher score indicates poorer functionality
Measured: 10 minutes
Nottingham Health Profile (NHP)
This tool comprises 38 questions in six domains, namely energy, pain, social isolation, physical mobility, emotional reactions, and sleep. Each domain is scored from 0 to 100. The total score is obtained by summing the scores obtained from the six domains. High scores indicate a good quality of life.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Nov 2022
- Primary completion1 May 2023
- Study completion1 Jul 2023
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 Selcuk 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
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015412
- Sponsor's protocol ID
- 2023/11-21
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life
- ClinicalTrials.gov ID
- NCT06015412
- Acronym / sponsor ID
- 2023/11-21
- Conditions
- Osteoarthritis, Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Aug 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.
To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Grade 1 osteoarthritis | – | Diagnostic Test: Radiographic classificationdisease stages 1 according to the Kellgren-Lawrence radiographic classification system |
| Grade 2 osteoarthritis | – | Diagnostic Test: Radiographic classificationdisease stages 2 according to the Kellgren-Lawrence radiographic classification system |
| Grade 3 osteoarthritis | – | Diagnostic Test: Radiographic classificationdisease stages 3 according to the Kellgren-Lawrence radiographic classification system |
| Grade 4 osteoarthritis | – | Diagnostic Test: Radiographic classificationdisease stages 4 according to the Kellgren-Lawrence radiographic classification system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosed with the same grade of knee OA in both knees by the responsible physician in the hospital
Key inclusion criteria (3 listed)
- having the same OA grade in both knees
- volunteering to participate in the study
- not having undergone previous lower extremity surgery
Key exclusion criteria (7 listed)
- neurological disorders;
- those with a history of surgery related to the lower extremities;
- those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis;
- those who had neurological, orthopedic, or cognitive disorders that would prevent walking;
- those with a diagnosis of diabetes, obesity, or rheumatological disorders;
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 |
|---|---|---|
| Radiographic classificationdisease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system | Diagnostic test | Grade 1 osteoarthritis, Grade 2 osteoarthritis, Grade 3 osteoarthritis, Grade 4 osteoarthritis |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 2 minutes
a 10-cm straight line with 0 on one end indicating no pain and 10 on the other end signifying unbearable pain. The participants were asked to mark the intensity of their current pain on the line
two-minute walk test (2MWT)
Time frame: 2 minutes
A 45-meter corridor was used for the 2MWT. The start and end points were marked, and the participants were asked to walk at a normal pace within these boundaries. The distance covered in two minutes was recorded
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 10 minutes
The questionnaire consists of 24 items, each scored from 0 to 4. The total score is obtained by summing the point equivalents of the responses given to all items. A higher score indicates poorer functionality
Nottingham Health Profile (NHP)
Time frame: 10 minutes
This tool comprises 38 questions in six domains, namely energy, pain, social isolation, physical mobility, emotional reactions, and sleep. Each domain is scored from 0 to 100. The total score is obtained by summing the scores obtained from the six domains. High scores indicate a good quality of life.
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 29 Aug 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.
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 Pain, run by Selcuk 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 7 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 29 Aug 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 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?
Visual Analog Scale (VAS) (time frame: 2 minutes). 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 29 Aug 2023.