- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036551
Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis
September 3, 2021 updated by: Nurhayat KORKMAZ, Hacettepe University
Relationship Between Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthrıtıs
Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification.
The Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue Scale (VAS) was used to assess pain.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to asses the functional status.
Self efficacy was assessed using the Arthritis Self Efficacy Scale (ASES).
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
community sample
Description
Inclusion Criteria:
- Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: After the participants were examined, evaluations were made before starting the physical therapy program.
|
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
Time Frame: After the participants were examined, evaluations were made before starting the physical therapy program.
|
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
Time Frame: After the participants were examined, evaluations were made before starting the physical therapy program.
|
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
Time Frame: After the participants were examined, evaluations were made before starting the physical therapy program.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hacettepe Üniversity, Intitue, Hacettepe University Health Sciences Institute
- Principal Investigator: Nurhayat Korkmaz, PhDstudent, Hacettepe University Health Sciences Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 20, 2018
Primary Completion (ACTUAL)
April 2, 2018
Study Completion (ACTUAL)
February 20, 2019
Study Registration Dates
First Submitted
August 27, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (ACTUAL)
September 5, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-FTR-NK-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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