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NCT Number: NCT07367126

Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location status: Recruiting

Location contact

Eser Kalaoglu, M.D.

CONTACT

[email protected]

+90 (212) 496 50 00 ext. 2126

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Clinical and Functional Assessment

Other

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 Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS). To ensure consistency and minimize measurement error, all anthropometric measurements, specifically weight and height, will be performed by the same researcher.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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)

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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).

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)

    Time frame: at baseline assessment

    Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) is used to evaluate physical functional limitations associated with knee osteoarthritis. It consists of seven items scored on a 5-point Likert scale. Raw scores are converted to a 0-100 scale, where higher scores indicate better physical function.

Study contacts

Contact information is provided by the study sponsor or research team.

Eser Kalaoglu, M.D.

CONTACT

[email protected]

+90 (212) 496 50 00 ext. 2126

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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