NCT05036551

Brief Summary

Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

March 20, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

13 days

First QC Date

August 27, 2021

Last Update Submit

September 3, 2021

Conditions

Keywords

KneeOsteoarthritisKinesiophobiaPainFunctional StatusSelf Efficacy

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale (VAS)

    Pain assessment, between 0-10 points. Low score low pain

    After the participants were examined, evaluations were made before starting the physical therapy program.

  • Tampa Scale for Kinesiophobia

    Kinesiophobia assessment, between 17-68 points. Low score low kinesiophobia.

    After the participants were examined, evaluations were made before starting the physical therapy program.

  • The Western Ontario and McMaster Universities Arthritis Index

    Functional state assessment, between 0-96 points. Low score good functional status.

    After the participants were examined, evaluations were made before starting the physical therapy program.

  • Arthritis Self Efficacy Scale

    Self Efficacy assessment, between 20-100 points. Low score low self-efficacy.

    After the participants were examined, evaluations were made before starting the physical therapy program.

Study Arms (2)

Stage 2 Knee osteoarthritis

The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception.

Diagnostic Test: Kellgren Lawrence classification

Stage 3 Knee osteoarthritis

The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception.

Diagnostic Test: Kellgren Lawrence classification

Interventions

The Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5)

Stage 2 Knee osteoarthritisStage 3 Knee osteoarthritis

Eligibility Criteria

Age40 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

community sample

You may qualify if:

  • Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.

You may not qualify if:

  • With a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisKinesiophobiaPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hacettepe Üniversity, Intitue

    Hacettepe University Health Sciences Institute

    STUDY DIRECTOR
  • Nurhayat Korkmaz, PhDstudent

    Hacettepe University Health Sciences Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

March 20, 2018

Primary Completion

April 2, 2018

Study Completion

February 20, 2019

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations