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

May 30, 2014 updated by: ArthroLab Inc.

A Cross-sectional Study to Explore the Osteoarthritis Structural Changes Assessed by MRI That Are Biomarkers of Neuropathic Pain in Knee Osteoarthritis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multicentre, cross-sectional observational pilot study. The presence of NP was determined based on use of the PainDETECT questionnaire (score 1 to 38), the score of which was defined for the purpose of the study as ≥ 13. A total of 50 OA patients with moderate to severe pain (VAS ≥ 40), 25 without the presence of NP (OA/NP-) (PainDETECT score < 13), and 25 with the presence of NP (OA/NP+) (PainDETECT score ≥ 13) were enrolled. Since this is a pilot study, we arbitrarily determined the number of patients at 50, which represents 25 patients per arm, a number deemed sufficient to identify the knee OA structural changes that could be preferentially associated with NP.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1W 4R4
        • Centre de Rhumatologie St. Louis
    • Quebec
      • Montreal, Quebec, Canada, H2L-1S6
        • Institut de Rhumatologie de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With neuropathic pain (PainDETECT ≥ 13)
Magnetic Resonance Imaging (MRI)
Other: Magnetic Resonance Imaging (MRI)
All participants from both arms will be subjected to MRI
No neuropathic pain (PainDETECT<13)
Magnetic Resonance Imaging (MRI)
Other: Magnetic Resonance Imaging (MRI)
All participants from both arms will be subjected to MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain
Time Frame: Baseline
The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.
Baseline

Other Outcome Measures

Outcome Measure
Time Frame
Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ArthroLab Inc.

Investigators

  • Principal Investigator: Jean-Pierre Raynauld, MD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A122-MER12H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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