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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733277
• Other study ID #: A122-MER12H
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: May 30, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: ArthroLab Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Neuralgia
• Neuropathic Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Magnetic Resonance Imaging (MRI)
All participants from both arms will be subjected to MRI

Locations

Country	Name	City	State
Canada	Institut de Rhumatologie de Montréal	Montreal	Quebec
Canada	Centre de Rhumatologie St. Louis	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
ArthroLab Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)		Baseline	No
Primary	Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain		Baseline	No
Secondary	Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain	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	No