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Clinical Trials/NCT05238857
NCT05238857
Completed
Not Applicable

Investigation of Predisposing Factors Affecting Pain at Rest, During Activity, and at Night in Patients With Knee Osteoarthritis

Istanbul University1 site in 1 country106 target enrollmentFebruary 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Istanbul University
Enrollment
106
Locations
1
Primary Endpoint
Pain Severity
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2022
End Date
August 21, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tansu Birinci

Principal Investigator

Istanbul University

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.
  • The exclusion criteria are as follows: (1) diagnosis of neurologic disease, rheumatoid arthritis, radiculopathy or peripheral neuropathy, psychiatric disease, (2) history of knee surgery or intraarticular corticosteroid injection within the past 6 months, (3) use of oral or topical analgesics for knee pain within the previous 6 months, (4) receiving any physical therapy intervention on the lower limbs in the previous 6 months, (5) inability to read and write in Turkish, (6) inability to follow simple instructions; and (7) having a pathology in visual ability and hearing.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain Severity

Time Frame: Baseline

The pain severity will be assessed with Visual Analogue Scale (VAS), which is a numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain.

Secondary Outcomes

  • Health-Related Quality of Life(Baseline)
  • The Isometric Muscle Strength of Lower Extremity(Baseline)
  • Functional Level of Lower Extremity(Baseline)
  • Active Range of Motion in Hip and Knee(Baseline)

Study Sites (1)

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