Knee OsteoarthritisNCT06753019
Somatosensory Amplification and Psychological and Functional Status In Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Amplification, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in… Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Knee Osteoarthritis, Amplification, Kinesiophobia
- What is being tested?
- survey assessment tools
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 10 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suleyman Demirel University Research and Application Hospital
Who may be able to join
- diagnosed with knee OA and had complaints for a minimum of 6 months
Who cannot join
- any rheumatological disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demirel University Faculty of Health Science
Isparta
+90 0246 211 32 67, saglikbilimlerif@sdu.edu.tr
About this study
Official title: The Relationship Between The Level of Somatosensory Amplification and Psychological and Functional Status in Patients With Knee Osteoarthritis
As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in correlating these factors with each other and in directing evaluation and treatment programs. Based on this, this study aims to demonstrate the relationship between the level of exaggeration of bodily sensations, psychological-functional status and perceived pain level in patients with knee pain due to knee OA.
Read the detailed description
This study is a screening study designed to reveal the relationship between the level of somatosensory amplification and the psychological-functional status and the level of pain felt in patients with knee pain due to knee OA. Considering the correlation of the features to be examined in the literature, it was found that the required sample size should be at least 80 with a test power of 95%, a type I error of 0.05 and an effect size of 0.34. 88 patients between the ages of 40-84 who have been diagnosed with knee OA and have complaints for at least 6 months will be included in the study. Patients with knee pain due to any rheumatologic disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma will be excluded from the study. The patients' sociodemographic characteristics such as age, height, weight, body mass index (BMI), gender, education level, marital status will be evaluated using the sociodemographic information form, somatosensory amplification levels will be evaluated with the 'Somatosensory Amplification Scale (SSAS)', the presence of kinesiophobia with the 'Tampa Kinesiophobia Scale (TSK)', pain levels with the Visual Analog Scale (VAS), the presence of depression with the 'Beck Depression Inventory (BDI)', and functional status with the total score of the 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)'. Statistical analysis of the data will be done using IBM SPSS Statistics version 20.0 (SPSS Inc., New York, USA). Kolmogorov-Smirnov test will be used to determine whether the variables are normally distributed, and the socio-demographic information of the participants and the scores they received from the SSAS, TAMPA, VAS, BDI and WOMAC questionnaires will be expressed as percentages, ratios or averages. The linear relationship between quantitative variables will be analyzed with Pearson correlation analysis, and the correlation between qualitative and quantitative variables will be analyzed with variance analysis (ANOVA), and independent samples t-test. In all analyses, p<0.05 will be considered statistically significant.
- Being tested
- survey assessment tools
- Keywords
- knee osteoarthritis, somatosensory amplification, kinesiophobia, pain, depression
- Medical subject headings
- Osteoarthritis, Knee, Kinesiophobia, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey assessment toolsOther
Functional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| assessment group | Patients diagnosed with knee OA, who have complaints for at least 6 months, and between the ages of 40-84 will be included in the study. Receives: Other: survey assessment tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory Amplification Scale
This scale is a 10-item scale developed to measure the magnification/exaggeration that individuals use while somatizing. Each item is scored between 1 and 5. Many of the items include a series of disturbing bodily sensations that are not indicative of illness. The total score is obtained by adding the scores from the items. An increase in the score from the scale indicates that bodily sensations are perceived exaggeratedly.
Measured: up to 2 weeks
Tampa Scale for Kinesiophobia
TSK is a 17-question questionnaire that evaluates fear of re-injury caused by movement, and has been validated and reliable in Turkish. The scale uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Strongly agree). A total score between 17-68 can be obtained based on the answers given by the person as a result of the questionnaire. A high score indicates a high level of kinesiophobia.
Measured: up to 2 weeks
Visual Analog Scale
The VAS is a 10cm line used to measure the intensity of pain, with 'no pain' at one end and 'extreme pain' at the other. Patients mark the point that best describes their pain intensity. The higher the score, the greater the intensity of pain.
Measured: up to 2 weeks
Beck Depression Inventory
BDI is a scale consisting of 21 questions in total used to determine the level of depression. Each question is evaluated between 0 and 3 points. A total score of 10 and above indicates the presence of depression. 10-18 points indicate minor depression, 19-29 points indicate moderate depression, and 30-63 points indicate severe depression.
Measured: up to 2 weeks
Western Ontario and McMaster Universities Arthritis Index
WOMAC is a 24-item scale developed to evaluate pain, joint stiffness, and physical functions in individuals with knee and hip OA. Total scores range from 0 to 96. A high score on the scale indicates high pain, stiffness, and functional limitations.
Measured: up to 2 weeks
sociodemographic data form
Demographic information (age, height, weight, gender) and socio-cultural (educational status, marital status) data of patients will be recorded.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion10 Jan 2025 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut ERGAN, Suleyman Demirel University
- Investigators
- mesut ergan, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753019
- Sponsor's protocol ID
- 09-27-2024/80/3
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between The Level of Somatosensory Amplification and Psychological and Functional Status in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06753019
- Acronym / sponsor ID
- 09-27-2024/80/3
- Keywords
- knee osteoarthritis, somatosensory amplification, kinesiophobia, pain, depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in correlating these factors with each other and in directing evaluation and treatment programs. Based on this, this study aims to demonstrate the relationship between the level of exaggeration of bodily sensations, psychological-functional status and perceived pain level in patients with knee pain due to knee OA.
Detailed description
This study is a screening study designed to reveal the relationship between the level of somatosensory amplification and the psychological-functional status and the level of pain felt in patients with knee pain due to knee OA. Considering the correlation of the features to be examined in the literature, it was found that the required sample size should be at least 80 with a test power of 95%, a type I error of 0.05 and an effect size of 0.34. 88 patients between the ages of 40-84 who have been diagnosed with knee OA and have complaints for at least 6 months will be included in the study. Patients with knee pain due to any rheumatologic disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma will be excluded from the study. The patients' sociodemographic characteristics such as age, height, weight, body mass index (BMI), gender, education level, marital status will be evaluated using the sociodemographic information form, somatosensory amplification levels will be evaluated with the 'Somatosensory Amplification Scale (SSAS)', the presence of kinesiophobia with the 'Tampa Kinesiophobia Scale (TSK)', pain levels with the Visual Analog Scale (VAS), the presence of depression with the 'Beck Depression Inventory (BDI)', and functional status with the total score of the 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)'. Statistical analysis of the data will be done using IBM SPSS Statistics version 20.0 (SPSS Inc., New York, USA). Kolmogorov-Smirnov test will be used to determine whether the variables are normally distributed, and the socio-demographic information of the participants and the scores they received from the SSAS, TAMPA, VAS, BDI and WOMAC questionnaires will be expressed as percentages, ratios or averages. The linear relationship between quantitative variables will be analyzed with Pearson correlation analysis, and the correlation between qualitative and quantitative variables will be analyzed with variance analysis (ANOVA), and independent samples t-test. In all analyses, p<0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment group | – | Other: survey assessment toolsPatients diagnosed with knee OA, who have complaints for at least 6 months, and between the ages of 40-84 will be included in the study. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suleyman Demirel University Research and Application Hospital
Key inclusion criteria (1 listed)
- diagnosed with knee OA and had complaints for a minimum of 6 months
Key exclusion criteria (1 listed)
- any rheumatological disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma
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 |
|---|---|---|
| survey assessment toolsFunctional and psychological status and the level of somatosensory amplification in patients with knee osteoarthritis will be evaluated with questionnaires. | Other | assessment group |
Primary outcome
Somatosensory Amplification Scale
Time frame: up to 2 weeks
This scale is a 10-item scale developed to measure the magnification/exaggeration that individuals use while somatizing. Each item is scored between 1 and 5. Many of the items include a series of disturbing bodily sensations that are not indicative of illness. The total score is obtained by adding the scores from the items. An increase in the score from the scale indicates that bodily sensations are perceived exaggeratedly.
Tampa Scale for Kinesiophobia
Time frame: up to 2 weeks
TSK is a 17-question questionnaire that evaluates fear of re-injury caused by movement, and has been validated and reliable in Turkish. The scale uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Strongly agree). A total score between 17-68 can be obtained based on the answers given by the person as a result of the questionnaire. A high score indicates a high level of kinesiophobia.
Visual Analog Scale
Time frame: up to 2 weeks
The VAS is a 10cm line used to measure the intensity of pain, with 'no pain' at one end and 'extreme pain' at the other. Patients mark the point that best describes their pain intensity. The higher the score, the greater the intensity of pain.
Beck Depression Inventory
Time frame: up to 2 weeks
BDI is a scale consisting of 21 questions in total used to determine the level of depression. Each question is evaluated between 0 and 3 points. A total score of 10 and above indicates the presence of depression. 10-18 points indicate minor depression, 19-29 points indicate moderate depression, and 30-63 points indicate severe depression.
Western Ontario and McMaster Universities Arthritis Index
Time frame: up to 2 weeks
WOMAC is a 24-item scale developed to evaluate pain, joint stiffness, and physical functions in individuals with knee and hip OA. Total scores range from 0 to 96. A high score on the scale indicates high pain, stiffness, and functional limitations.
sociodemographic data form
Time frame: up to 2 weeks
Demographic information (age, height, weight, gender) and socio-cultural (educational status, marital status) data of patients will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- 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.
mesut ergan study director
Suleyman Demirel 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 and Amplification, run by Suleyman Demirel 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mesut ERGAN, asst. prof. (+90 02462113730, mesutergan@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory Amplification Scale (time frame: up to 2 weeks). The study lists 6 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 31 Dec 2024.