Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

Официальное название

Presence of Neuropathic Pain in Knee Osteoarthritis: Relationship Between Pain Severity and Functional Status

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Clinical and Functional Assessment
  All participants will undergo a one-time, cross-sectional clinical assessment. Comprehensive demographic and clinical data, including age, body mass index (BMI), educational level, occupation, and marital status, will be recorded for each participant. Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS). Functional status and symptoms related to knee osteoarthritis will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee I

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: at baseline assessment]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: at baseline assessment]

Вторичные конечные точки (1)

• Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) [Срок оценки: at baseline assessment]

Критерии участия

Критерии включения

• Diagnosed with Knee OA according to ACR criteria.
• Knee pain for more than 3 months.
• Voluntary participation.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Physical Medicine and Rehabilitation Training and Research Hospital — Istanbul

Публикации

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• Perrot S. Osteoarthritis pain. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):90-7. doi: 10.1016/j.berh.2015.04.017. Epub 2015 May 16. PMID 26267003
• Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24. PMID 21907813

Идентификаторы

NCT: NCT07367126 · İstPRMTRH-EK6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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