- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06336278
Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zonguldak, Turkey, 67100
- Zonguldak Bulent Ecevit Universitiy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria for knee osteoarthritis group:
- 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
Exclusion Criteria for knee osteoarthritis group:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Knee Osteoarthritis
Patients who have knee pain at least 6 months, 45-75 years old, kellgren-lawrence grade 1-3
|
Pressure algometer is used to detect pain pressure treshold.
|
|
Control
Subjects who have not knee pain, 45-75 years old
|
Pressure algometer is used to detect pain pressure treshold.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Pressure Treshold
Time Frame: Day 1
|
Algometer was used to detect pressure pain threshold.
Higher scores mean better outcomes.
|
Day 1
|
|
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.
|
Day 1
|
|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing
Time Frame: Day 1
|
Pain Catastrophizing Scale was used to assess chronic pain related symptoms.
Minimum value is 0 , maximum value is 52.
Higher values means worse outcomes.
|
Day 1
|
|
Depression
Time Frame: Day 1
|
Beck Depression Inventory was used to assess depression.
Minimum value is 0 , maximum value is 63.
Higher values means worse outcomes.
|
Day 1
|
|
Visuel Analog Scala
Time Frame: Day 1
|
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.
|
Day 1
|
|
Western Ontario and McMaster Universitesies Osteoarthritis Index
Time Frame: Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19/03/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
Clinical Trials on Pressure Algometer
-
Xianwei ZhangCompleted
-
Julia FinkelCoolCad Electronics, LLC; University of Maryland EngineeringCompleted
-
Centre Hospitalier Universitaire, AmiensCH CORBIERecruitingRecovery | Heat Stress | Mechanical Stress | HSP70 | Cumulative Response | Hot-water ImmersionFrance
-
Seoul National University HospitalUnknownPostoperative Pain
-
Ruhr University of BochumCompletedHealthy Subjects | Complex Regional Pain Syndrome Type I of the Upper Limb | Unilateral Limb Pain of Other OriginGermany
-
Poznan University of Medical SciencesCompletedTemporomandibular Joint DisordersPoland
-
Meir Medical CenterClalit Health ServicesCompletedFasciitis, Plantar | Plantar Calcaneal SpurIsrael
-
Tokat Gaziosmanpasa UniversityUnknown
-
Duke UniversityCompleted
-
Centre Hospitalier Universitaire de NīmesCompleted