Trial Outcomes & Findings for Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis (NCT NCT01733277)
NCT ID: NCT01733277
Last Updated: 2014-07-02
Results Overview
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
Baseline
Results posted on
2014-07-02
Participant Flow
Participant milestones
| Measure |
Presence of Neuropathic Pain
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI
|
Absence of Neuropathic Pain
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Presence of Neuropathic Pain
n=25 Participants
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI
|
Absence of Neuropathic Pain
n=25 Participants
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-90 years
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
PainDetect (0-38)
|
21.1 units on a scale
STANDARD_DEVIATION 5.4 • n=99 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
VAS Pain (0-100)
|
67 units on a scale
STANDARD_DEVIATION 13 • n=99 Participants
|
62 units on a scale
STANDARD_DEVIATION 14 • n=107 Participants
|
64 units on a scale
STANDARD_DEVIATION 13 • n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Number of participant analyzed Per-protocol
Outcome measures
| Measure |
Presence of Neuropathic Pain
n=25 Participants
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI
|
Absence of Neuropathic Pain
n=25 Participants
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI
|
|---|---|---|
|
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Partial Meniscal Extrusion (Medial)
|
14 participants
|
7 participants
|
|
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Partial Meniscal Extrusion (Lateral)
|
5 participants
|
1 participants
|
|
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Bone Marrow Lesions (Lateral Plateau)
|
15 participants
|
8 participants
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Presence of Neuropathic Pain
n=25 Participants
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI
|
Absence of Neuropathic Pain
n=25 Participants
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI
|
|---|---|---|
|
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
|
45 units on a scale
Standard Deviation 21
|
|
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
|
43 units on a scale
Standard Deviation 17
|
|
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
|
51 units on a scale
Standard Deviation 24
|
|
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
|
45 units on a scale
Standard Deviation 23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Presence of Neuropathic Pain
n=25 Participants
Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)
MRI
|
Absence of Neuropathic Pain
n=25 Participants
Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT \< 13)
MRI
|
|---|---|---|
|
Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)
|
5.7 mg/L
Standard Deviation 6.6
|
4.3 mg/L
Standard Deviation 2.9
|
Adverse Events
Presence of Neuropathic Pain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Absence of Neuropathic Pain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place