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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArthroLab Inc.
ClinicalTrials.gov Identifier:
NCT01733277
First received: November 16, 2012
Last updated: May 30, 2014
Last verified: May 2014
  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: Magnetic Resonance Imaging (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:
  • Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733277

Locations
Canada, Quebec
Institut de Rhumatologie de Montréal
Montreal, Quebec, Canada, H2L-1S6
Canada
Centre de Rhumatologie St. Louis
Quebec, Canada, G1W 4R4
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
Results First Received: February 7, 2014
Last Updated: May 30, 2014
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 July 31, 2014