Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Physical Therapy Program (Procedure)
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.
干预措施: Standard Physical Therapy Program (Procedure)
结局指标
主要结局
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
时间窗: 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.
次要结局
- Change in Visual Analog Scale (VAS) Pain Score(Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.)
研究者
Zeynep Karakuzu Güngör
Specialist in Physical Medicine and Rehabilitation
Kanuni Sultan Suleyman Training and Research Hospital