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Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis (ALEX-KOA)

2026年6月11日 更新者:Zeynep Karakuzu Güngör、Kanuni Sultan Suleyman Training and Research Hospital

Knee osteoarthritis is one of the most common degenerative joint diseases and is associated with chronic pain, functional impairment, and reduced quality of life. Psychological factors may influence both symptom severity and response to treatment. Alexithymia, characterized by difficulty in identifying and expressing emotions, has been associated with poorer outcomes in chronic pain conditions.

The aim of this prospective observational study is to investigate whether the presence of alexithymia affects the clinical response to a standardized physical therapy program in patients with knee osteoarthritis. Participants will undergo a standard physical therapy regimen and will be evaluated before treatment, immediately after treatment, and 6 weeks after treatment completion. Pain, functional status, alexithymia, anxiety, and depression will be assessed using validated clinical scales. The study seeks to determine whether alexithymia is an independent predictor of treatment response in patients with knee osteoarthritis.

研究概览

地位

尚未招聘

详细说明

Detailed Description

Knee osteoarthritis (KOA) is one of the most prevalent degenerative musculoskeletal disorders and represents a major cause of chronic pain, disability, and reduced quality of life worldwide. Although structural joint degeneration is a hallmark of the disease, increasing evidence suggests that psychological factors also contribute to pain perception, functional impairment, and variability in treatment outcomes.

Alexithymia is a personality construct characterized by difficulty in identifying, describing, and expressing emotions. Previous studies have demonstrated that alexithymia is associated with greater pain severity, poorer functional status, and unfavorable clinical outcomes in various chronic pain conditions. However, its influence on the response to conservative treatment in patients with knee osteoarthritis has not been adequately investigated.

The primary objective of this prospective observational cohort study is to evaluate whether alexithymia influences the clinical response to a standardized physical therapy program in patients with knee osteoarthritis. The secondary objective is to determine whether alexithymia independently predicts treatment outcomes after adjustment for potential confounding factors.

Patients aged 40 to 75 years with clinically and radiographically diagnosed knee osteoarthritis will be enrolled. All participants will receive a standardized physical therapy program consisting of Transcutaneous Electrical Nerve Stimulation (TENS), superficial heat therapy (hot pack), therapeutic ultrasound, and a home exercise program over a three-week treatment period.

Clinical evaluations will be performed at baseline, immediately after completion of treatment, and six weeks after treatment completion. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), alexithymia using the Toronto Alexithymia Scale-20 (TAS-20), and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Participants will be classified as alexithymia-positive or alexithymia-negative according to their baseline TAS-20 scores.

The primary outcome measure will be the change in WOMAC total score. Secondary outcome measures will include changes in VAS and HADS scores. Multivariable regression analyses will be performed to determine whether alexithymia is an independent predictor of response to physical therapy after adjustment for demographic and clinical variables.

研究类型

观察性的

注册 (估计的)

60

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 40 to 75 years with clinically and radiographically confirmed knee osteoarthritis according to the American College of Rheumatology (ACR) criteria and Kellgren-Lawrence grade II or III disease. Participants will be recruited consecutively from the outpatient Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital. All eligible patients who meet the inclusion criteria and provide written informed consent will receive a standardized physical therapy program and will be prospectively followed to evaluate the effect of alexithymia on treatment response.

描述

Inclusion Criteria:

Age between 40 and 75 years. Diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.

Kellgren-Lawrence grade II or III on radiographic evaluation. Presence of symptomatic knee pain requiring physical therapy. Willingness and ability to participate in the standardized physical therapy program.

Ability to complete study questionnaires and clinical assessments. Provision of written informed consent prior to participation.

Exclusion Criteria:

Age younger than 40 years or older than 75 years. Kellgren-Lawrence grade I or grade IV knee osteoarthritis. Previous knee arthroplasty or major knee surgery on the affected side. Lower extremity surgery within the previous 6 months. Intra-articular corticosteroid, hyaluronic acid, platelet-rich plasma, prolotherapy, or stem cell injection into the knee within the previous 3 months.

Physical therapy for knee osteoarthritis within the previous 3 months. Acute knee trauma or fracture. Inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).

Fibromyalgia or chronic widespread pain syndrome. Active infection or malignancy. Neurological disorders significantly affecting lower extremity function or balance (e.g., stroke, Parkinson's disease, multiple sclerosis).

Severe cognitive impairment or major psychiatric illness that may interfere with study participation or questionnaire completion.

Contraindications to physical therapy modalities (TENS, therapeutic ultrasound, or superficial heat therapy).

Regular opioid analgesic use or other medications that may substantially influence pain perception.

Pregnancy or breastfeeding. Inability to comply with the treatment protocol or follow-up assessments. Participation in another interventional clinical study during the study period. Refusal or inability to provide written informed consent.

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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
干预/治疗
Alexithymia-Positive Cohort
Participants with knee osteoarthritis who have a Toronto Alexithymia Scale-20 (TAS-20) score of 61 or higher at baseline. All participants will receive the same standardized physical therapy program and will be followed prospectively to evaluate treatment response.

All participants will receive the same standardized physical therapy program consisting of:

Transcutaneous Electrical Nerve Stimulation (TENS) for 20 minutes, Superficial heat therapy (hot pack) for 20 minutes, Therapeutic ultrasound (1 MHz, 1.5 W/cm²) for 5 minutes, A home exercise program targeting the muscles around the knee.

The treatment will be administered 5 days per week for 3 weeks, for a total of 15 sessions.

Alexithymia-Negative Cohort
Participants with knee osteoarthritis who have a Toronto Alexithymia Scale-20 (TAS-20) score of less than 61 at baseline. All participants will receive the same standardized physical therapy program and will be followed prospectively to evaluate treatment response.

All participants will receive the same standardized physical therapy program consisting of:

Transcutaneous Electrical Nerve Stimulation (TENS) for 20 minutes, Superficial heat therapy (hot pack) for 20 minutes, Therapeutic ultrasound (1 MHz, 1.5 W/cm²) for 5 minutes, A home exercise program targeting the muscles around the knee.

The treatment will be administered 5 days per week for 3 weeks, for a total of 15 sessions.

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 the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
大体时间:Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
The primary outcome is the change in the WOMAC total score, which assesses pain, stiffness, and physical function in patients with knee osteoarthritis.
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.

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, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Pain intensity will be assessed using the Visual Analog Scale (VAS), and the change from baseline after treatment will be evaluated.
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Change in Hospital Anxiety and Depression Scale (HADS) Score
大体时间:Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Changes in anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.

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。

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10月25日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月11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

  • KSUH-OA-ALEX-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Not applicable, as Individual Participant Data (IPD) will not be shared.

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

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