Knee OsteoarthritisNCT05036551
Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Kellgren Lawrence classification
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2018to 20 Feb 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.
Who cannot join
- With a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: Relationship Between Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthrıtıs
Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.
Read the detailed description
Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification. The Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue Scale (VAS) was used to assess pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to asses the functional status. Self efficacy was assessed using the Arthritis Self Efficacy Scale (ASES).
- Conditions
- Knee Osteoarthritis
- Being tested
- Kellgren Lawrence classification
- Keywords
- Knee, Osteoarthritis, Kinesiophobia, Pain, Functional Status, Self Efficacy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kellgren Lawrence classificationDiagnostic test
The Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5)
| Study group | Role | What they receive |
|---|---|---|
| Stage 2 Knee osteoarthritis | The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception. Receives: Diagnostic Test: Kellgren Lawrence classification | |
| Stage 3 Knee osteoarthritis | The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception. Receives: Diagnostic Test: Kellgren Lawrence classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Pain assessment, between 0-10 points. Low score low pain
Measured: After the participants were examined, evaluations were made before starting the physical therapy program.
Tampa Scale for Kinesiophobia
Kinesiophobia assessment, between 17-68 points. Low score low kinesiophobia.
Measured: After the participants were examined, evaluations were made before starting the physical therapy program.
The Western Ontario and McMaster Universities Arthritis Index
Functional state assessment, between 0-96 points. Low score good functional status.
Measured: After the participants were examined, evaluations were made before starting the physical therapy program.
Arthritis Self Efficacy Scale
Self Efficacy assessment, between 20-100 points. Low score low self-efficacy.
Measured: After the participants were examined, evaluations were made before starting the physical therapy program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start20 Mar 2018
- Primary completion2 Apr 2018
- Study completion20 Feb 2019
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.
- More trials run by Hacettepe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhayat KORKMAZ, Hacettepe University
- Investigators
- Hacettepe Üniversity, Intitue, Study director, Hacettepe University Health Sciences InstituteNurhayat Korkmaz, PhDstudent, Principal investigator, Hacettepe University Health Sciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036551
- Sponsor's protocol ID
- HU-FTR-NK-01
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthrıtıs
- ClinicalTrials.gov ID
- NCT05036551
- Acronym / sponsor ID
- HU-FTR-NK-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Kinesiophobia, Pain, Functional Status, Self Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 5 Sep 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.
Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.
Detailed description
Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification. The Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue Scale (VAS) was used to assess pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to asses the functional status. Self efficacy was assessed using the Arthritis Self Efficacy Scale (ASES).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 2 Knee osteoarthritis | – | Diagnostic Test: Kellgren Lawrence classificationThe Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception. |
| Stage 3 Knee osteoarthritis | – | Diagnostic Test: Kellgren Lawrence classificationThe Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.
Key exclusion criteria (1 listed)
- With a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections
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 |
|---|---|---|
| Kellgren Lawrence classificationThe Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5) | Diagnostic test | Stage 2 Knee osteoarthritis, Stage 3 Knee osteoarthritis |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: After the participants were examined, evaluations were made before starting the physical therapy program.
Pain assessment, between 0-10 points. Low score low pain
Tampa Scale for Kinesiophobia
Time frame: After the participants were examined, evaluations were made before starting the physical therapy program.
Kinesiophobia assessment, between 17-68 points. Low score low kinesiophobia.
The Western Ontario and McMaster Universities Arthritis Index
Time frame: After the participants were examined, evaluations were made before starting the physical therapy program.
Functional state assessment, between 0-96 points. Low score good functional status.
Arthritis Self Efficacy Scale
Time frame: After the participants were examined, evaluations were made before starting the physical therapy program.
Self Efficacy assessment, between 20-100 points. Low score low self-efficacy.
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 5 Sep 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.
Hacettepe Üniversity, Intitue study director
Hacettepe University Health Sciences Institute
Nurhayat Korkmaz, PhDstudent principal investigator
Hacettepe University Health Sciences Institute
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 Hacettepe 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 1 inclusion and 1 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 5 Sep 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?
Visual Analogue Scale (VAS) (time frame: After the participants were examined, evaluations were made before starting the physical therapy program.). 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 5 Sep 2021.