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Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07367126
Enrollment
102
Registered
2026-01-26
Start date
2025-12-20
Completion date
2026-04-30
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthristis

Keywords

Pain Intensity, Functional Status, Neuropathic Pain, Knee Osteoarthritis

Brief summary

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.

Detailed description

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).

Interventions

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.

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS)at baseline assessmentPain 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)at baseline assessmentWestern 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

MeasureTime frameDescription
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)at baseline assessmentKnee 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTEser Kalaoglu, M.D.
eserkalaoglu@hotmail.com+90 (212) 496 50 00
PRINCIPAL_INVESTIGATOREser Kalaoglu, M.D.

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026