Osteoarthritis, KneeNCT05238857
Investigation of Predisposing Factors Affecting Pain in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the factors affecting pain in patients with knee osteoarthritis (OA). This study will be carried out following the "Helsinki Declaration", by selecting 106 volunteers who were diagnosed with knee OA, who applied to the Department of Orthopedics between February 2022 and August 2023 and met… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Assessment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2022to 21 Aug 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over the age of 40 years with knee osteoarthritis
Who may be able to join
- Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included.
- The exclusion criteria are as follows: (1) diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease, (2) history of knee surgery or intraarticular corticosteroid injection within the past 6 months, (3) use of oral or topical analgesics for knee pain within the previous 6 months, (4) receiving any physical therapy intervention on the lower limbs in the previous 6 months, (5) inability to read and write in Turkish, (6) inability to follow simple instructions; and (7) having a pathology in visual ability and hearing.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Predisposing Factors Affecting Pain at Rest, During Activity, and at Night in Patients With Knee Osteoarthritis
This study aims to determine the factors affecting pain in patients with knee osteoarthritis (OA). This study will be carried out following the "Helsinki Declaration", by selecting 106 volunteers who were diagnosed with knee OA, who applied to the Department of Orthopedics between February 2022 and August 2023 and met the inclusion criteria.
Before the evaluation, all the volunteers participating in the study will be informed about the purpose of the study, its duration, and the evaluations to be made. Consent will be obtained from all volunteers participating in the study with an "Informed Voluntary Consent Form". Demographic and clinical characteristics of all patients who voluntarily accepted to participate in the study will be questioned with the "Knee Osteoarthritis Evaluation Form". Quality of life, pain, range of motion (ROM), muscle strength, presence of comorbidity, and functional evaluation will be recorded on the form.
Read the detailed description
Inclusion criteria:
- Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included
Exclusion criteria:
- Diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease
- History of knee surgery or intraarticular corticosteroid injection within the past 6 months
- Use of oral or topical analgesics for knee pain within the previous 6 months
- Receiving any physical therapy intervention on the lower limbs in the previous 6 months,
- Inability to read and write in Turkish
- Inability to follow simple instructions
- Having a pathology in visual ability and hearing
Assessments: Pain by Visual Analog Scale (VAS), ROM by digital goniometer, muscle strength by "Hand-held" dynamometer (Lafeyette Instrument®, Lafayette, IN), presence of comorbidity by Charlson Comorbidity Index, functional status WOMAC (Western Ontario and McMaster Universities) index, and quality of life will be evaluated with Short Form-12 (SF-12).
Statistics: The data obtained within the scope of the research will be analyzed with the Statistical Package for Social Science (IBM SPSS Statistics New York, USA) version 20.0. The distribution of the data will be evaluated with the "Shapiro Wilk Test". In the statistical analysis of the study, continuous variables will be shown with mean, standard deviation, minimum-maximum values, and categorical variables will be shown with frequency and percentage values. The relationship between VAS and independent factors will be analyzed with the "Pearson correlation test", and the effect of independent factors on the VAS score will be analyzed with "Linear Regression". In all analyses, p<0.05 (two-sided) values will be considered statistically significant.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Assessment
- Keywords
- Pain, Knee, Osteoarthritis, Function
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
There will be no intervention. Only assessments will be taken from the patients and data will be analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
The pain severity will be assessed with Visual Analogue Scale (VAS), which is a numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain.
Measured: Baseline
Secondary outcomes (4)
Health-Related Quality of Life
The health-quality of life of participants will be assessed with Short Form-12, which is a widely used reliable, valid, and responsive measure of quality of life in general population.
Measured: Baseline
The Isometric Muscle Strength of Lower Extremity
The isometric strength of the iliopsoas, gluteus medius, quadriceps, and hamstring muscles of the affected side will be measured using a handheld dynamometer measuring kilogram per newton (Nicholas Manual Muscle Tester; model 01160, The Lafayette Instrument Company, Lafayette, Indiana). Each participant will be informed verbally about the technique of the test before starting. Each limb will assessed three times, with a 30-sec interval between tests, and the mean value will be calculated for analysis.
Measured: Baseline
Functional Level of Lower Extremity
Functionality will be assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used reliable, valid, and responsive measure of outcome in people with osteoarthritis of the knee.
Measured: Baseline
Active Range of Motion in Hip and Knee
The active range of motion, including hip flexion, knee flexion, and extension will be measured by using a digital goniometer (Baseline Evaluation Instrument, Fabrication Enterprises, Inc., White Plains, NY). Each participant will be informed verbally about the technique of the test before starting. The affected side will be assessed three times, with a 30-sec interval between tests, and the best value will be calculated for analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start21 Feb 2022
- Primary completion21 Dec 2022
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University
- Investigators
- Tansu Birinci, PT, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238857
- Sponsor's protocol ID
- 11012022
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2022
- Last updated
- 4 Oct 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Predisposing Factors Affecting Pain at Rest, During Activity, and at Night in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05238857
- Acronym / sponsor ID
- 11012022
- Conditions
- Osteoarthritis, Knee
- Keywords
- Pain, Knee, Osteoarthritis, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 14 Feb 2022 (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 the factors affecting pain in patients with knee osteoarthritis (OA). This study will be carried out following the "Helsinki Declaration", by selecting 106 volunteers who were diagnosed with knee OA, who applied to the Department of Orthopedics between February 2022 and August 2023 and met the inclusion criteria.
Before the evaluation, all the volunteers participating in the study will be informed about the purpose of the study, its duration, and the evaluations to be made. Consent will be obtained from all volunteers participating in the study with an "Informed Voluntary Consent Form". Demographic and clinical characteristics of all patients who voluntarily accepted to participate in the study will be questioned with the "Knee Osteoarthritis Evaluation Form". Quality of life, pain, range of motion (ROM), muscle strength, presence of comorbidity, and functional evaluation will be recorded on the form.
Detailed description
Inclusion criteria:
- Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included
Exclusion criteria:
- Diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease
- History of knee surgery or intraarticular corticosteroid injection within the past 6 months
- Use of oral or topical analgesics for knee pain within the previous 6 months
- Receiving any physical therapy intervention on the lower limbs in the previous 6 months,
- Inability to read and write in Turkish
- Inability to follow simple instructions
- Having a pathology in visual ability and hearing
Assessments: Pain by Visual Analog Scale (VAS), ROM by digital goniometer, muscle strength by "Hand-held" dynamometer (Lafeyette Instrument®, Lafayette, IN), presence of comorbidity by Charlson Comorbidity Index, functional status WOMAC (Western Ontario and McMaster Universities) index, and quality of life will be evaluated with Short Form-12 (SF-12).
Statistics: The data obtained within the scope of the research will be analyzed with the Statistical Package for Social Science (IBM SPSS Statistics New York, USA) version 20.0. The distribution of the data will be evaluated with the "Shapiro Wilk Test". In the statistical analysis of the study, continuous variables will be shown with mean, standard deviation, minimum-maximum values, and categorical variables will be shown with frequency and percentage values. The relationship between VAS and independent factors will be analyzed with the "Pearson correlation test", and the effect of independent factors on the VAS score will be analyzed with "Linear Regression". In all analyses, p<0.05 (two-sided) values will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over the age of 40 years with knee osteoarthritis
Key inclusion criteria (2 listed)
- Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included.
- The exclusion criteria are as follows: (1) diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease, (2) history of knee surgery or intraarticular corticosteroid injection within the past 6 months, (3) use of oral or topical analgesics for knee pain within the previous 6 months, (4) receiving any physical therapy intervention on the lower limbs in the previous 6 months, (5) inability to read and write in Turkish, (6) inability to follow simple instructions; and (7) having a pathology in visual ability and hearing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AssessmentThere will be no intervention. Only assessments will be taken from the patients and data will be analyzed. | Other | – |
Primary outcome
Pain Severity
Time frame: Baseline
The pain severity will be assessed with Visual Analogue Scale (VAS), which is a numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain.
4 secondary outcomes
Health-Related Quality of Life
Time frame: Baseline
The Isometric Muscle Strength of Lower Extremity
Time frame: Baseline
Functional Level of Lower Extremity
Time frame: Baseline
Active Range of Motion in Hip and Knee
Time frame: Baseline
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 4 Oct 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.
Tansu Birinci, PT, PhD principal investigator
Istanbul University - Cerrahpasa
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, Knee, run by Istanbul 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 2 inclusion and 0 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 4 Oct 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?
Pain Severity (time frame: Baseline). 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 4 Oct 2023.