Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis

NCT01733277 | Completed Results

• 1 other identifier: A122-MER12H
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to identify osteoarthritis (OA) structural changes, as assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm).

Conditions

Neuropathic Pain; Knee Osteoarthritis

Keywords

Neuropathic pain; Knee osteoarthritis; MRI

Outcome Measures

Primary Outcomes (1)

• Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain

  Baseline

Secondary Outcomes (1)

• Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain

  Baseline

Other Outcomes (1)

• Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)

  Baseline

Study Arms (2)

With neuropathic pain (PainDETECT ≥ 13)

Magnetic Resonance Imaging (MRI)

Other: Magnetic Resonance Imaging (MRI)

No neuropathic pain (PainDETECT<13)

Magnetic Resonance Imaging (MRI)

Other: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) OTHER

All participants from both arms will be subjected to MRI

No neuropathic pain (PainDETECT<13); With neuropathic pain (PainDETECT ≥ 13)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Presence or absence of neuropathic pain on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm)

You may qualify if:

• Individuals of either sex, aged 40 years and more;
• Followed in an ambulatory clinic;
• Presenting with primary OA of the knee according to American College of Rheumatology (ACR) criteria;
• With an OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
• Knee pain for at least 1 month out of the 3 months preceding the study;
• Visual Analog Scale (VAS) of pain while walking on a flat surface ≥ 40 mm;
• Agrees to sign the Informed Consent Form;
• Not taking part in another clinical trial;
• Agrees to respect the protocol.

You may not qualify if:

• Other bone and articular diseases (antecedents and/or current signs);
• Presenting with isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only;
• Knee surgery on the study knee;
• Comorbidities that restrict knee function;
• Had received any investigational drug within 30 days or 5 half lives (whichever is greater) prior to entering the study;
• Unable to give informed consent;
• Counter-indication to an MRI examination;
• Baseline Visit cartilage volume cannot be calculated from the MRI due to advanced OA or any other technical reason;
• Abnormal findings and or any other condition, which, in the Investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data through MRI to achieve the objectives of the study.

Sponsors & Collaborators

• ArthroLab Inc.: lead

Study Sites (2)

Institut de Rhumatologie de Montréal

Montreal, Quebec, H2L-1S6, Canada

Location

Centre de Rhumatologie St. Louis

Québec, Quebec, G1W 4R4, Canada

Location

Related Publications (1)

• Roubille C, Raynauld JP, Abram F, Paiement P, Dorais M, Delorme P, Bessette L, Beaulieu AD, Martel-Pelletier J, Pelletier JP. The presence of meniscal lesions is a strong predictor of neuropathic pain in symptomatic knee osteoarthritis: a cross-sectional pilot study. Arthritis Res Ther. 2014 Dec 14;16(6):507. doi: 10.1186/s13075-014-0507-z.

  PMID: 25497320 DERIVED

MeSH Terms

Conditions

Neuralgia; Osteoarthritis, Knee

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr Jean-Pierre Pelletier
• Organization: ArthroLab Inc.

dr@jppelletier.ca

15148908000

Study Officials

• Jean-Pierre Raynauld, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 27, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-05

Locations

CA (2)