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临床试验/NCT05238857
NCT05238857已完成不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2022年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Pain Severity

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Pain Severity

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tansu Birinci

Principal Investigator

Istanbul University

研究点 (1)

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