Knee OsteoarthritisNCT06336278
Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Central Sensitisation, run by Selda Sarıkaya at 1 site in Turkey (Türkiye).
Trial summary
Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Central Sensitisation, Kinesiophobia
- What is being tested?
- Pressure Algometer
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 2023
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria for control group: * Being a healthy volunteer between the ages of 45-75 * No pain in the knee and forearm * No mechanical, inflammatory, endocrine, degenerative, degenerative, systemic comorbidities that may affect the knee joint * Body mass index below 35 Exclusion Criteria for control group: * Diagnosed with knee osteoarthritis * Presence of uncontrolled systemic disease * Cooperation limitation or cognitive impairment * Presence of chronic painful disease, rheumatologic disease, peripheral neuropathy * Body mass index of 35 and above
Who may be able to join
- Being a healthy volunteer between the ages of 45-75
- Being diagnosed with knee osteoarthritis according to ACR diagnostic criteria
- Knee pain for at least 6 months
- Kellgren-Lawrence 1, 2 or 3 radiologic grade of knee OA
- Body mass index below 35
Who cannot join
- Presence of chronic widespread painful diseases other than osteoarthritis (fibromyalgia syndrome etc.), rheumatologic disease, peripheral neuropathy
- Presence of uncontrolled systemic disease
- Cooperation limitation or cognitive impairment
- Active arthritis in the knee joint to be evaluated
- Presence of prosthesis in the knees
- Pain in the forearm
- Body mass index of 35 and above
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit Universitiy
Zonguldak, 67100
About this study
Official title: The Relationship Between Central Sensitization and Kinesiophobia in Patients With Knee Osteoarthritis
Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.
Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.
Read the detailed description
Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.
- Conditions
- Knee Osteoarthritis, Central Sensitisation, Kinesiophobia
- Being tested
- Pressure Algometer
- Keywords
- pain pressure treshold, algometer, knee osteoarthritis, central sensitization, kinesiophobia
- Medical subject headings
- Osteoarthritis, Knee, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure AlgometerDiagnostic test
Pressure algometer is used to detect pain pressure treshold.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Patients who have knee pain at least 6 months, 45-75 years old, kellgren-lawrence grade 1-3 Receives: Diagnostic Test: Pressure Algometer | |
| Control | Subjects who have not knee pain, 45-75 years old Receives: Diagnostic Test: Pressure Algometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Treshold
Algometer was used to detect pressure pain threshold. Higher scores mean better outcomes.
Measured: Day 1
Central Sensitization
Central Sensitization Inventory was used to evaluate central sensitization. Minimum value is 0 , maximum value is 100. Higher values means worse outcomes.
Measured: Day 1
Kinesiophobia
The presence of kinesiophobia was assessed with Tampa Scale af Kinesiophobia. Minimum value is 17 , maximum value is 68. Higher values means worse outcomes.
Measured: Day 1
Secondary outcomes (4)
Pain Catastrophizing
Pain Catastrophizing Scale was used to assess chronic pain related symptoms. Minimum value is 0 , maximum value is 52. Higher values means worse outcomes.
Measured: Day 1
Depression
Beck Depression Inventory was used to assess depression. Minimum value is 0 , maximum value is 63. Higher values means worse outcomes.
Measured: Day 1
Visuel Analog Scala
Visuel Analog Scala was used to assess pain intensity. Patients' pain (0=no pain, 10=intolerable pain) on a 100 mm horizontal line. The marked value was recorded in millimeters.
Measured: Day 1
Western Ontario and McMaster Universitesies Osteoarthritis Index
Pain and functional status of the patients included in our study assessment was performed using this index, consists of a total of three subscales and 24 questions, each question is scored between 0 and 4 (0=none, 4=very severe). Minimum value is 0, maximum value is 100. Higher scores indicate an increase in pain and stiffness and a decline in physical function.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Selda Sarıkaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selda Sarıkaya, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336278
- Sponsor's protocol ID
- 19/03/2024
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Central Sensitization and Kinesiophobia in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06336278
- Acronym / sponsor ID
- 19/03/2024
- Conditions
- Knee Osteoarthritis, Central Sensitisation, Kinesiophobia
- Keywords
- pain pressure treshold, algometer, knee osteoarthritis, central sensitization, kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Selda SarıkayaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Mar 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.
Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.
Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.
Detailed description
Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | Diagnostic Test: Pressure AlgometerPatients who have knee pain at least 6 months, 45-75 years old, kellgren-lawrence grade 1-3 |
| Control | – | Diagnostic Test: Pressure AlgometerSubjects who have not knee pain, 45-75 years old |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria for control group: * Being a healthy volunteer between the ages of 45-75 * No pain in the knee and forearm * No mechanical, inflammatory, endocrine, degenerative, degenerative, systemic comorbidities that may affect the knee joint * Body mass index below 35 Exclusion Criteria for control group: * Diagnosed with knee osteoarthritis * Presence of uncontrolled systemic disease * Cooperation limitation or cognitive impairment * Presence of chronic painful disease, rheumatologic disease, peripheral neuropathy * Body mass index of 35 and above
Key inclusion criteria (5 listed)
- Being a healthy volunteer between the ages of 45-75
- Being diagnosed with knee osteoarthritis according to ACR diagnostic criteria
- Knee pain for at least 6 months
- Kellgren-Lawrence 1, 2 or 3 radiologic grade of knee OA
- Body mass index below 35
Key exclusion criteria (7 listed)
- Presence of chronic widespread painful diseases other than osteoarthritis (fibromyalgia syndrome etc.), rheumatologic disease, peripheral neuropathy
- Presence of uncontrolled systemic disease
- Cooperation limitation or cognitive impairment
- Active arthritis in the knee joint to be evaluated
- Presence of prosthesis in the knees
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 |
|---|---|---|
| Pressure AlgometerPressure algometer is used to detect pain pressure treshold. | Diagnostic test | Control, Knee Osteoarthritis |
Primary outcome
Pain Pressure Treshold
Time frame: Day 1
Algometer was used to detect pressure pain threshold. Higher scores mean better outcomes.
Central Sensitization
Time frame: Day 1
Central Sensitization Inventory was used to evaluate central sensitization. Minimum value is 0 , maximum value is 100. Higher values means worse outcomes.
Kinesiophobia
Time frame: Day 1
The presence of kinesiophobia was assessed with Tampa Scale af Kinesiophobia. Minimum value is 17 , maximum value is 68. Higher values means worse outcomes.
4 secondary outcomes
Pain Catastrophizing
Time frame: Day 1
Depression
Time frame: Day 1
Visuel Analog Scala
Time frame: Day 1
Western Ontario and McMaster Universitesies Osteoarthritis Index
Time frame: Day 1
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 22 Apr 2024.
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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 Knee Osteoarthritis and Central Sensitisation, run by Selda Sarıkaya 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 5 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 22 Apr 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?
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 Pressure Treshold (time frame: Day 1). The study lists 3 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 22 Apr 2024.