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临床试验/NCT06446973
NCT06446973已完成不适用

Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions

Istanbul Aydın University2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Pain Severity and Range of Motion Assessment

研究概览

简要总结

Meniscal tears are common knee injuries, affecting a wide demographic from young athletes to the elderly population, often resulting from traumatic sports-related incidents or degenerative processes associated with aging. The impact of meniscal injuries extends beyond the immediate physical damage, influencing pain perception, balance, functional performance, and ultimately, the quality of life. Despite advancements in diagnostic and therapeutic strategies, the comprehensive effects of meniscal tears on these domains remain inadequately explored, particularly regarding their correlation with objective measures of pain, balance, muscle strength and quality of life.

The meniscus plays a crucial role in knee joint stability, load distribution, and shock absorption. Damage to this fibrocartilaginous structure can significantly impair knee function, leading to altered biomechanics, decreased joint stability, and increased risk of osteoarthritis. Previous research has predominantly focused on the surgical and non-surgical management of meniscal tears, with less attention to the broader implications on patients' daily lives, particularly in terms of postural stability, risk of falls, and overall physical well-being.

This study aims to bridge this knowledge gap by quantitatively assessing the risk of meniscal tears on pain levels, balance, functional performance, and quality of life. By comparing objective measurements between individuals with meniscal tears and healthy controls, the investigators seek to elucidate the multifaceted impact of these injuries. Understanding these relationships is crucial for developing targeted rehabilitation strategies that address not only the mechanical aspects of the injury but also the associated functional and quality of life concerns.

Our hypothesis was that individuals with meniscal lesions have worse pain, functional performance and quality of life compared to those without such injuries and also pain directly influences balance, functional performance, and quality of life in patients with meniscal injuries.

详细描述

This study included a total of 70 participants, divided into two groups: 35 patients diagnosed with meniscus tear and 35 healthy individuals. The investigators determined this sample size using the G-Power software to ensure a 95% power level and an effect size of 0.8, following the methodology recommended by Faul et al.

The criteria for inclusion in the meniscopathy group;

  • Volunteering to participate in the research,
  • To be between ages of 18-60,
  • Not having systemic or neurological issues interfering with assessment completion,
  • Have meniscus pathologies in one or both knees confirmed by MRI.

The criteria for inclusion in the control group;

  • To be between ages of 18-60,
  • Not have any orthopedic, neurological, or systemic conditions, Volunteer to participate in the study. Exlusion criteria from the study;
  • Having had additional knee surgery or fractures in the affected lower extremity within the last year
  • Having had autoimmune or inflammatory diseases,
  • Having had involved in a physiotherapy program for the knee in the past six months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the research,
  • To be between ages of 18-60,
  • Not having systemic or neurological issues interfering with assessment completion,
  • Have meniscus pathologies in one or both knees confirmed by MRI.
  • The criteria for inclusion in the control group;
  • To be between ages of 18-60,
  • Not have any orthopedic, neurological, or systemic conditions,
  • Volunteer to participate in the study.

排除标准

  • - Having had additional knee surgery or fractures in the affected lower extremity within the last year
  • Having had autoimmune or inflammatory diseases,
  • Having had involved in a physiotherapy program for the knee in the past six months.

结局指标

主要结局

Pain Severity and Range of Motion Assessment

时间窗: through study completion, an average of 1 year

Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.There are numbers from 0 to 10. 0 is classified as no pain and 10 as very severe.

Muscle Strength Assessment

时间窗: through study completion, an average of 1 year

Hamstring muscle group and Quadriceps Femoris muscle were evaluated.The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions

Balance Assessment

时间窗: through study completion, an average of 1 year

Berg Balance Scale (BBS) was utilized to determine fall risk and postural control.This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance.

Physical Performance Assessment- TUG

时间窗: through study completion, an average of 1 year

Timed Up and Go Test (TUG ). For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch

Physical Performance Assessment- 5TSTS

时间窗: through study completion, an average of 1 year

Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.

Quality of Life Assessment

时间窗: through study completion, an average of 1 year

The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET).a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being

次要结局

未报告次要终点

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barış CELBEK

Lecturer

Istanbul Aydın University

研究点 (2)

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