NCT06336278

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

March 19, 2024

Last Update Submit

April 19, 2024

Conditions

Keywords

pain pressure tresholdalgometerknee osteoarthritiscentral sensitizationkinesiophobia

Outcome Measures

Primary Outcomes (3)

  • Pain Pressure Treshold

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

    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.

    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.

    Day 1

Secondary Outcomes (4)

  • Pain Catastrophizing

    Day 1

  • Depression

    Day 1

  • Visuel Analog Scala

    Day 1

  • Western Ontario and McMaster Universitesies Osteoarthritis Index

    Day 1

Study Arms (2)

Knee Osteoarthritis

Patients who have knee pain at least 6 months, 45-75 years old, kellgren-lawrence grade 1-3

Diagnostic Test: Pressure Algometer

Control

Subjects who have not knee pain, 45-75 years old

Diagnostic Test: Pressure Algometer

Interventions

Pressure AlgometerDIAGNOSTIC_TEST

Pressure algometer is used to detect pain pressure treshold.

ControlKnee Osteoarthritis

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bulent Ecevit Universitiy

Zonguldak, 67100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeKinesiophobia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 28, 2024

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations