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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With neuropathic pain (PainDETECT ≥ 13) | Magnetic Resonance Imaging (MRI) |
| |
| No neuropathic pain (PainDETECT<13) | Magnetic Resonance Imaging (MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | All participants from both arms will be subjected to MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Baseline |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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Presence or absence of neuropathic pain on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm)
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Raynauld, MD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Rhumatologie de Montréal | Montreal | Quebec | H2L-1S6 | Canada | ||
| Centre de Rhumatologie St. Louis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25497320 | Derived | Roubille C, Raynauld JP, Abram F, Paiement P, Dorais M, Delorme P, Bessette L, Beaulieu AD, Martel-Pelletier J, Pelletier JP. The presence of meniscal lesions is a strong predictor of neuropathic pain in symptomatic knee osteoarthritis: a cross-sectional pilot study. Arthritis Res Ther. 2014 Dec 14;16(6):507. doi: 10.1186/s13075-014-0507-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Presence of Neuropathic Pain | Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13) MRI |
| FG001 | Absence of Neuropathic Pain | Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13) MRI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Presence of Neuropathic Pain | Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13) MRI |
| BG001 | Absence of Neuropathic Pain | Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13) MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain | Number of participant analyzed Per-protocol | Posted | Number | participants | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Presence of Neuropathic Pain | Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13) MRI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jean-Pierre Pelletier | ArthroLab Inc. | 15148908000 | 26666 | dr@jppelletier.ca |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Québec |
| Quebec |
| G1W 4R4 |
| Canada |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PainDetect (0-38) | The presence of neuropathic was determined based on use of PainDETECT questionnaire which can discriminate patients with neuropathic knee pain (score ≥ 13; the higher the score, the worst is the pain). | Mean | Standard Deviation | units on a scale |
|
| VAS Pain (0-100) | Visual Analogue Scale (VAS) for global knee pain (0 mm = no pain, 100 mm = most severe pain) | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP) | Posted | Mean | Standard Deviation | mg/L | Baseline |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Absence of Neuropathic Pain | Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13) MRI | 0 | 25 | 0 | 25 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| WOMAC (Stiffness: 0-8) |
|
| WOMAC (Function: 0-68) |
|