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NCT Number: NCT06336278

Relationship Between Central Sensitization and Kinesiophobia in 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.

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Key information

Conditions

Knee Osteoarthritis Anxiety Disorders Arthritis Central Sensitisation Joint Diseases Kinesiophobia Mental Disorders Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Phobic Disorders Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bulent Ecevit Universitiy

Zonguldak, 67100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure Algometer

Diagnostic Test

Pressure algometer is used to detect pain pressure treshold.

Primary outcomes

  1. Pain Pressure Treshold

    Time frame: Day 1

    Algometer was used to detect pressure pain threshold. Higher scores mean better outcomes.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Selda Sarıkaya

Other

Registry information

Official study title

The Relationship Between Central Sensitization and Kinesiophobia in Patients With Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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