Investigation of Predisposing Factors Affecting Pain in Patients With Knee Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women over the age of 40 years with knee osteoarthritis

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.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life	The health-quality of life of participants will be assessed with Short Form-12, which is a widely used reliable, valid, and responsive measure of quality of life in general population.	Baseline
The Isometric Muscle Strength of Lower Extremity	The isometric strength of the iliopsoas, gluteus medius, quadriceps, and hamstring muscles of the affected side will be measured using a handheld dynamometer measuring kilogram per newton (Nicholas Manual Muscle Tester; model 01160, The Lafayette Instrument Company, Lafayette, Indiana). Each participant will be informed verbally about the technique of the test before starting. Each limb will assessed three times, with a 30-sec interval between tests, and the mean value will be calculated for analysis.	Baseline
Functional Level of Lower Extremity	Functionality will be assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used reliable, valid, and responsive measure of outcome in people with osteoarthritis of the knee.	Baseline
Active Range of Motion in Hip and Knee	The active range of motion, including hip flexion, knee flexion, and extension will be measured by using a digital goniometer (Baseline Evaluation Instrument, Fabrication Enterprises, Inc., White Plains, NY). Each participant will be informed verbally about the technique of the test before starting. The affected side will be assessed three times, with a 30-sec interval between tests, and the best value will be calculated for analysis.	Baseline

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Tansu Birinci, PT, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Knee; Function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 11012022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No