Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

NCT07367126 | Recruiting

• 1 other identifier: İstPRMTRH-EK6
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthristis

Keywords

Pain Intensity; Functional Status; Neuropathic Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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)

  at baseline assessment

• 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).

  at baseline assessment

Secondary Outcomes (1)

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

  at baseline assessment

Study Arms (2)

Group 1 (Case)

Patients with Knee OA and Neuropathic Pain (DN4 score ≥ 4)

Other: Clinical and Functional Assessment

Group 2 (Control)

Patients with Knee OA without Neuropathic Pain (DN4 score \< 4)

Other: Clinical and Functional Assessment

Interventions

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.

Group 1 (Case); Group 2 (Control)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Ohtori S, Orita S, Yamashita M, Ishikawa T, Ito T, Shigemura T, Nishiyama H, Konno S, Ohta H, Takaso M, Inoue G, Eguchi Y, Ochiai N, Kishida S, Kuniyoshi K, Aoki Y, Arai G, Miyagi M, Kamoda H, Suzkuki M, Nakamura J, Furuya T, Kubota G, Sakuma Y, Oikawa Y, Suzuki M, Sasho T, Nakagawa K, Toyone T, Takahashi K. Existence of a neuropathic pain component in patients with osteoarthritis of the knee. Yonsei Med J. 2012 Jul 1;53(4):801-5. doi: 10.3349/ymj.2012.53.4.801.

  PMID: 22665349 RESULT

• Hochman JR, Davis AM, Elkayam J, Gagliese L, Hawker GA. Neuropathic pain symptoms on the modified painDETECT correlate with signs of central sensitization in knee osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1236-42. doi: 10.1016/j.joca.2013.06.023.

  PMID: 23973136 RESULT

• Davis MP. What is new in neuropathic pain? Support Care Cancer. 2007 Apr;15(4):363-72. doi: 10.1007/s00520-006-0156-0. Epub 2006 Nov 28.

  PMID: 17131133 RESULT

• Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.

  PMID: 18003941 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pain; Neuralgia; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eser Kalaoglu, M.D.

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eser Kalaoglu, M.D.

CONTACT

+90 (212) 496 50 00; eserkalaoglu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: December 20, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 1 year following article publication
• Access Criteria: Qualified researchers who present a methodologically robust proposal aimed at fulfilling the objectives of the approved project

Locations

TU (1)