Investigation of Predisposing Factors Affecting Pain in Patients With Knee Osteoarthritis

NCT ID: NCT05238857

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2023-08-21

Brief Summary

This study aims to determine the factors affecting pain in patients with knee osteoarthritis (OA). This study will be carried out following the "Helsinki Declaration", by selecting 106 volunteers who were diagnosed with knee OA, who applied to the Department of Orthopedics between February 2022 and August 2023 and met the inclusion criteria.

Before the evaluation, all the volunteers participating in the study will be informed about the purpose of the study, its duration, and the evaluations to be made. Consent will be obtained from all volunteers participating in the study with an "Informed Voluntary Consent Form". Demographic and clinical characteristics of all patients who voluntarily accepted to participate in the study will be questioned with the "Knee Osteoarthritis Evaluation Form". Quality of life, pain, range of motion (ROM), muscle strength, presence of comorbidity, and functional evaluation will be recorded on the form.

Detailed Description

Inclusion criteria:

• Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included

Exclusion criteria:

• Diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease
• History of knee surgery or intraarticular corticosteroid injection within the past 6 months
• Use of oral or topical analgesics for knee pain within the previous 6 months
• Receiving any physical therapy intervention on the lower limbs in the previous 6 months,
• Inability to read and write in Turkish
• Inability to follow simple instructions
• Having a pathology in visual ability and hearing

Assessments: Pain by Visual Analog Scale (VAS), ROM by digital goniometer, muscle strength by "Hand-held" dynamometer (Lafeyette Instrument®, Lafayette, IN), presence of comorbidity by Charlson Comorbidity Index, functional status WOMAC (Western Ontario and McMaster Universities) index, and quality of life will be evaluated with Short Form-12 (SF-12).

Statistics: The data obtained within the scope of the research will be analyzed with the Statistical Package for Social Science (IBM SPSS Statistics New York, USA) version 20.0. The distribution of the data will be evaluated with the "Shapiro Wilk Test". In the statistical analysis of the study, continuous variables will be shown with mean, standard deviation, minimum-maximum values, and categorical variables will be shown with frequency and percentage values. The relationship between VAS and independent factors will be analyzed with the "Pearson correlation test", and the effect of independent factors on the VAS score will be analyzed with "Linear Regression". In all analyses, p<0.05 (two-sided) values will be considered statistically significant.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Assessment

There will be no intervention. Only assessments will be taken from the patients and data will be analyzed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Tansu Birinci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tansu Birinci, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

11012022

Identifier Type: -

Identifier Source: org_study_id