Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Knee OA according to ACR criteria.

Knee pain for more than 3 months.

Voluntary participation.

Disqualifiers

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.

Trial population

The source population for this cross-sectional controlled study is the adult patient population diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria, recruited from the Physical Medicine and Rehabilitation outpatient clinic at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Clinical and Functional Assessment

    Other intervention

    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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Group 1 (Case)1 intervention
Group B: Group 2 (Control)1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS)

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)

Time frame
at baseline assessment
2

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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).

Time frame
at baseline assessment

Secondary outcomes

1

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

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.

Time frame
at baseline assessment

Other outcomes

Sponsors and contacts

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