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

This study is not yet open for participant recruitment.
Verified November 2012 by ArthroLab Inc.
Sponsor:
Information provided by (Responsible Party):
ArthroLab Inc.
ClinicalTrials.gov Identifier:
NCT01733277
First received: November 16, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Neuropathic Pain
Knee Osteoarthritis
Other: MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study to Explore the Osteoarthritis Structural Changes Assessed by MRI That Are Biomarkers of Neuropathic Pain in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by ArthroLab Inc.:

Primary Outcome Measures:
  • To correlate the level of neuropathic pain with the severity of OA structural changes (cartilage volume and defects, bone marrow lesions, meniscal tears and extrusion, synovitis). [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the correlation between the presence of neuropathic pain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores (total, pain, function, stiffness). [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To assess the correlation between the presence of NP and biological markers of inflammation [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Presence of neuropathic pain
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
Other: MRI
Absence of neuropathic pain
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)
Other: MRI

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733277

Contacts
Contact: Jean-Pierre Pelletier, MD 514-890-8000 ext 26666 dr@jppelletier.ca
Contact: Patrice Paiement, MSc 514-890-8000 ext 28943 ppaiement@arthrolab.com

Locations
Canada, Quebec
Institut de Rhumatologie de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2L-1S6
Contact: Jean-Pierre Pelletier, MD    514-890-8000 ext 26666    dr@jppelletier.ca   
Principal Investigator: Jean-Pierre Raynauld, MD         
Canada
Centre de Rhumatologie St. Louis Not yet recruiting
Quebec, Canada, G1W 4R4
Contact: André Beaulieu, MD    418-659-5757      
Principal Investigator: André Beaulieu, MD         
Sponsors and Collaborators
ArthroLab Inc.
Investigators
Principal Investigator: Jean-Pierre Raynauld, MD Université de Montréal
  More Information

No publications provided

Responsible Party: ArthroLab Inc.
ClinicalTrials.gov Identifier: NCT01733277     History of Changes
Other Study ID Numbers: A122-MER12H
Study First Received: November 16, 2012
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by ArthroLab Inc.:
Neuropathic pain
Knee osteoarthritis
MRI

Additional relevant MeSH terms:
Neuralgia
Osteoarthritis
Osteoarthritis, Knee
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014