Neuropathic pain and its effect on pain level and function in knee osteoarthritis.
Presence of Neuropathic Pain in Knee Osteoarthritis: Relationship Between Pain Severity and Functional Status
This project will see how common neuropathic pain is and how it affects pain and daily function in people with knee osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07367126 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional controlled clinical study enrolling patients who meet ACR criteria for knee osteoarthritis and have had knee pain for more than three months. Participants will be screened with the DN4 questionnaire and divided into groups based on a DN4 score threshold of 4/10, then compared on pain intensity and functional outcome measures. Investigators will collect demographic and clinical data and exclude people with recent knee surgery, recent injections or physical therapy, inflammatory arthritis, major neurologic or psychiatric conditions, or decompensated organ failure. The goal is to determine the prevalence of a neuropathic pain component and quantify its association with pain severity and functional status.
Who should consider this trial
Good fit: Adults diagnosed with knee osteoarthritis by ACR criteria who have had knee pain for over three months and who have not had recent knee surgery, recent trauma, intra-articular injections, or physical therapy and do not have major psychiatric, neurologic, inflammatory, or decompensated organ disease.
Not a fit: People with recent knee surgery or injections, recent knee trauma, inflammatory arthritis, severe psychiatric or neurologic disorders, or decompensated cardiac, renal, or hepatic failure are unlikely to benefit from participation.
Why it matters
Potential benefit: If findings confirm a neuropathic component in some patients, it could help guide more targeted pain treatments and improve pain control and functional outcomes for people with knee OA.
How similar studies have performed: Questionnaire-based studies using instruments like the DN4 have previously identified neuropathic pain features in roughly 19–37% of knee OA patients, so the approach is established though reported rates vary.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Istanbul
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Eser Kalaoglu, M.D. — Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Study coordinator: Eser Kalaoglu, M.D.
- Email: eserkalaoglu@hotmail.com
- Phone: +90 (212) 496 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.