N/A
N=50
Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis
Neuropathic Pain · Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01733277 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain — 14; 7; 5; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Magnetic Resonance Imaging (MRI) (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- ArthroLab Inc.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain |
14; 7; 5; 1; 15; 8 | — |
| 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 |
62; 45; 59; 43; 62; 51 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01733277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.