Knee Osteoarthritis, Neuropathic Pain
Conditions
Keywords
Neuropathic pain, Knee osteoarthritis, MRI
Brief 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).
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.
Interventions
OTHERMagnetic Resonance Imaging (MRI)
All participants from both arms will be subjected to MRI
Sponsors
ArthroLab Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | 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. |
Other
| Measure | Time frame |
|---|---|
| Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) | Baseline |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Presence of Neuropathic Pain Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI | 25 |
| Absence of Neuropathic Pain Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Presence of Neuropathic Pain | Absence of Neuropathic Pain | Total |
|---|---|---|---|
| Age, Customized 40-90 years | 25 participants | 25 participants | 50 participants |
| PainDetect (0-38) | 21.1 units on a scale STANDARD_DEVIATION 5.4 | 8.1 units on a scale STANDARD_DEVIATION 2.6 | 14.6 units on a scale STANDARD_DEVIATION 7.8 |
| Region of Enrollment Canada | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
| VAS Pain (0-100) | 67 units on a scale STANDARD_DEVIATION 13 | 62 units on a scale STANDARD_DEVIATION 14 | 64 units on a scale STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Time frame: Baseline
Population: Number of participant analyzed Per-protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Partial Meniscal Extrusion (Medial) | 14 participants |
| Presence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Partial Meniscal Extrusion (Lateral) | 5 participants |
| Presence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Bone Marrow Lesions (Lateral Plateau) | 15 participants |
| Absence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Partial Meniscal Extrusion (Medial) | 7 participants |
| Absence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Partial Meniscal Extrusion (Lateral) | 1 participants |
| Absence of Neuropathic Pain | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Bone Marrow Lesions (Lateral Plateau) | 8 participants |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Presence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (total: 0-96) | 62 units on a scale | Standard Deviation 15 |
| Presence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Pain: 0-20) | 59 units on a scale | Standard Deviation 15 |
| Presence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Stiffness: 0-8) | 62 units on a scale | Standard Deviation 19 |
| Presence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Function: 0-68) | 62 units on a scale | Standard Deviation 16 |
| Absence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Function: 0-68) | 45 units on a scale | Standard Deviation 23 |
| Absence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (total: 0-96) | 45 units on a scale | Standard Deviation 21 |
| Absence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Stiffness: 0-8) | 51 units on a scale | Standard Deviation 24 |
| Absence of Neuropathic Pain | Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain | WOMAC (Pain: 0-20) | 43 units on a scale | Standard Deviation 17 |
Other Pre-specified
Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Presence of Neuropathic Pain | Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) | 5.7 mg/L | Standard Deviation 6.6 |
| Absence of Neuropathic Pain | Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) | 4.3 mg/L | Standard Deviation 2.9 |