Presence of Neuropathic Pain in Knee Osteoarthritis: Relationship Between Pain Severity and Functional Status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Osteoarthritis (OA) is a degenerative joint disease characterized by structural changes such as cartilage loss and osteophyte formation, leading to functional limitations and disability. Pain in knee OA involves a complex pathophysiological structure including both nociceptive and neuropathic mechanisms. Identifying the neuropathic pain component is clinically significant for improving quality of life and functional recovery. This cross-sectional controlled clinical study aims to determine the prevalence of neuropathic pain in patients with knee OA and evaluate its impact on pain severity and functional status. Patients will be categorized based on the Douleur Neuropathique 4 (DN4) questionnaire and assessed using various pain and functional scales.
详细描述
Osteoarthritis (OA) is a degenerative joint disease characterized by structural alterations, including focal cartilage loss, osteophyte formation, subchondral sclerosis, and synovitis. Given the growing elderly population, the prevalence of OA is rising, frequently leading to significant functional limitations and disability. Pain, the most prominent symptom of OA, serves as a critical measure for monitoring disease activity and treatment efficacy.
Recent evidence suggests that OA-related pain involves a complex pathophysiological structure, incorporating both nociceptive and neuropathic mechanisms. Studies indicate that approximately 19-37% of patients with knee OA exhibit symptoms consistent with neuropathic pain. Identifying this neuropathic component is clinically essential, as it may respond differently to conventional analgesics; thus, recognizing it is vital for optimizing functional recovery and quality of life.
This cross-sectional controlled clinical trial aims to determine the prevalence of neuropathic pain in patients with knee OA and evaluate its impact on pain severity and functional status. Participants diagnosed with knee OA according to the American College of Rheumatology (ACR) criteria will be recruited and categorized into two groups based on a Douleur Neuropathique 4 (DN4) questionnaire score threshold of 4/10.
For all participants, comprehensive demographic and clinical data, including age, body mass index (BMI), educational level, occupation, and marital status, will be recorded. To ensure consistency and minimize measurement error, all anthropometric assessments will be performed by a single researcher. The following standardized assessment tools will be administered to all participants: Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Knee OA according to ACR criteria.
- •Knee pain for more than 3 months.
- •Voluntary participation.
排除标准
- •History of surgical intervention in the affected knee.
- •History of trauma to the affected knee within the last 6 months.
- •History of intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) or physical therapy involving the affected knee within the last 6 months.
- •Presence of severe psychiatric disorders such as severe depression, anxiety disorder, or psychosis.
- •Diagnosis of central nervous system diseases, including Parkinson's disease or multiple sclerosis.
- •Diagnosis of inflammatory arthritis, such as Rheumatoid Arthritis or Ankylosing Spondylitis.
- •Severe cognitive impairment.
- •Chronic decompensated cardiac, renal, or hepatic failure.
- •Severe psychiatric, neurological, or kognitive disorders.
- •Decompensated cardiac, renal, or hepatic failure.
研究组 & 干预措施
Group 1 (Case)
Patients with Knee OA and Neuropathic Pain (DN4 score ≥ 4)
干预措施: Clinical and Functional Assessment (Other)
Group 2 (Control)
Patients with Knee OA without Neuropathic Pain (DN4 score < 4)
干预措施: Clinical and Functional Assessment (Other)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: at baseline assessment
Pain intensity was assessed using a 10 cm scale, where one end represents "no pain" and the other represents "most severe pain." Patients were asked to rate their pain on a scale from 0 (no pain) to 10 (most severe pain)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: at baseline assessment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of subscales evaluating pain (5 items), stiffness (2 items), and physical function (17 items). Using a 5-point Likert scale, scores range from 0 (representing the best status/no pain) to 96 (representing the worst status/extreme pain).
次要结局
- Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)(at baseline assessment)
研究者
Eser Kalaoglu
Principal Investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital