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Effect of Preoperative Kinesiophobia on Clinical Outcomes Following Arthroscopic Meniscus Surgery (MEN-KIN)

2026年6月12日 更新者:Erdal Güngör、Medipol University

Effect of Preoperative Kinesiophobia on Clinical Success in Patients Undergoing Arthroscopic Surgery for Meniscal Tears

Meniscal tears are among the most common knee injuries and frequently require arthroscopic surgical treatment when conservative management fails or mechanical symptoms persist. Although surgical techniques have improved clinical outcomes, postoperative recovery is influenced not only by structural pathology but also by psychological factors. Kinesiophobia, defined as an excessive and debilitating fear of movement due to pain or the expectation of reinjury, may negatively affect rehabilitation adherence, functional recovery, and pain perception.

This prospective observational study aims to investigate the effect of preoperative kinesiophobia on postoperative clinical outcomes in patients undergoing arthroscopic surgery for meniscal tears. Adult patients diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging and scheduled for arthroscopic surgery will be enrolled. Preoperative demographic and clinical characteristics, pain intensity, functional status, and kinesiophobia levels will be assessed using validated outcome measures. Postoperative evaluations will be performed three months after surgery to determine changes in pain and functional outcomes. The relationship between preoperative kinesiophobia and postoperative clinical success will be analyzed. The findings of this study may help identify patients at risk for suboptimal recovery and support the development of individualized rehabilitation strategies.

研究概览

地位

尚未招聘

详细说明

Meniscal tears are among the most common knee injuries encountered in orthopedic practice and represent a major cause of knee pain, mechanical symptoms, and functional impairment. Although conservative treatment may be effective in selected patients, arthroscopic surgery remains a widely performed procedure for individuals with persistent symptoms or mechanical dysfunction. Despite advances in surgical techniques and standardized rehabilitation protocols, postoperative recovery varies considerably among patients with similar structural pathology, suggesting that factors beyond the anatomical lesion may influence clinical outcomes.

Psychological factors have increasingly been recognized as important determinants of recovery after musculoskeletal injuries and orthopedic surgery. Among these, kinesiophobia, defined as an excessive and debilitating fear of movement resulting from pain or the anticipation of reinjury, may negatively affect rehabilitation adherence, physical activity, muscle performance, and overall functional recovery. Patients with high levels of kinesiophobia may avoid movement, resulting in delayed restoration of knee function and persistent disability. However, evidence specifically evaluating the influence of preoperative kinesiophobia on outcomes following arthroscopic meniscal surgery remains limited.

The present study is designed as a prospective, single-center, observational cohort study to investigate the effect of preoperative kinesiophobia on postoperative clinical success in patients undergoing arthroscopic surgery for meniscal tears. Adult patients aged 18 to 65 years with a diagnosis of a meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic surgery will be consecutively enrolled.

Baseline assessments will include demographic characteristics, body mass index, symptom duration, affected side, meniscal tear localization, and the type of arthroscopic procedure performed. Pain intensity will be evaluated using the Visual Analog Scale (VAS), functional status will be assessed using the Lysholm Knee Score, and fear of movement will be measured using the Tampa Scale for Kinesiophobia (TSK). All outcome measures will be recorded preoperatively and at the postoperative third month, providing a standardized assessment of changes in pain, function, and kinesiophobia over the early recovery period.

Participants will be categorized according to their preoperative kinesiophobia levels, and postoperative clinical outcomes will be compared between groups. In addition, correlation analyses will be performed to determine the relationship between preoperative kinesiophobia and postoperative pain and functional recovery. Appropriate statistical methods will be used to evaluate between-group differences and associations, with statistical significance defined as p < 0.05.

The findings of this study are expected to clarify the role of preoperative kinesiophobia as a potential predictor of postoperative clinical success following arthroscopic meniscal surgery. Improved understanding of this relationship may facilitate the identification of patients at risk for suboptimal recovery and support the development of individualized perioperative rehabilitation strategies that incorporate both physical and psychological components.

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will consist of adult patients aged 18-65 years who are diagnosed with a meniscal tear by clinical examination and magnetic resonance imaging (MRI) and are scheduled to undergo arthroscopic meniscal surgery at the Department of Orthopedics and Traumatology of a single tertiary care center. Eligible participants who provide written informed consent and meet the inclusion criteria will be enrolled consecutively. Preoperative and postoperative clinical assessments will be performed according to the study protocol.

描述

Inclusion Criteria:

Adults aged 18 to 65 years. Diagnosis of meniscal tear confirmed by clinical examination and magnetic resonance imaging (MRI).

Patients scheduled to undergo arthroscopic meniscal surgery. Ability to understand and complete the study questionnaires. Willingness to participate and provide written informed consent. Availability for both preoperative assessment and postoperative 3-month follow-up.

Exclusion Criteria:

Previous surgery on the affected knee. Concomitant anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), or collateral ligament injuries requiring surgical treatment.

Advanced knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4). History of inflammatory rheumatic disease or active joint infection. Neurological disorders affecting lower extremity function or balance. Severe psychiatric disorders or cognitive impairment preventing completion of questionnaires.

Pregnancy. Inability or unwillingness to provide written informed consent. Inability to attend the 3-month postoperative follow-up.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
High Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate high preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK). Participants will undergo standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.
Low Kinesiophobia Group
Patients with meniscal tears scheduled for arthroscopic surgery who demonstrate low preoperative kinesiophobia based on the Tampa Scale for Kinesiophobia (TSK). Participants will undergo the same standard surgical treatment and routine postoperative rehabilitation and will be evaluated preoperatively and at the postoperative third month for pain and functional outcomes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Lysholm Knee Score
大体时间:Baseline and postoperative 3 months
To evaluate the change in knee function using the Lysholm Knee Score from baseline (preoperative assessment) to the postoperative 3-month follow-up in patients undergoing arthroscopic surgery for meniscal tears.
Baseline and postoperative 3 months

次要结果测量

结果测量
措施说明
大体时间
Change in Visual Analog Scale (VAS) Pain Score
大体时间:Baseline (preoperative) and postoperative 3 months.
Assessment of postoperative pain intensity using the 10-cm Visual Analog Scale (VAS). Lower scores indicate less pain.
Baseline (preoperative) and postoperative 3 months.
Change in Tampa Scale for Kinesiophobia (TSK) Score
大体时间:Baseline (preoperative) and postoperative 3 months.
Assessment of fear of movement using the Tampa Scale for Kinesiophobia. Higher scores indicate greater kinesiophobia.
Baseline (preoperative) and postoperative 3 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Erdal Güngör, M.D、Istanbul Medipol University, Department of Orthopedics and Traumatology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月25日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • MBH-ORTHO-2026-001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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