Knee Osteoarthritis Clinical Trial
Official title:
The Relationship Between Central Sensitization and Kinesiophobia in Patients With Knee Osteoarthritis
NCT number | NCT06336278 |
Other study ID # | 19/03/2024 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2022 |
Est. completion date | December 1, 2023 |
Verified date | April 2024 |
Source | Bulent Ecevit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zonguldak Bulent Ecevit Universitiy | Zonguldak |
Lead Sponsor | Collaborator |
---|---|
Selda Sarikaya |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Pressure Treshold | Algometer was used to detect pressure pain threshold. Higher scores mean better outcomes. | Day 1 | |
Primary | Central Sensitization | Central Sensitization Inventory was used to evaluate central sensitization. Minimum value is 0 , maximum value is 100. Higher values means worse outcomes. | Day 1 | |
Primary | 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. | Day 1 | |
Secondary | 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. | Day 1 | |
Secondary | Depression | Beck Depression Inventory was used to assess depression. Minimum value is 0 , maximum value is 63. Higher values means worse outcomes. | Day 1 | |
Secondary | 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. | Day 1 | |
Secondary | 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. | Day 1 |
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