Neuropathic PainNCT01733277
Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis
An observational study of Neuropathic Pain and Knee Osteoarthritis, run by ArthroLab Inc. at 2 sites in Canada.
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 ≥… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Neuropathic Pain, Knee Osteoarthritis
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Presence or absence of neuropathic pain on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm)
Who may be able to join
- 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;
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- Agrees to sign the Informed Consent Form;
- Not taking part in another clinical trial;
- Agrees to respect the protocol.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut de Rhumatologie de Montréal
Montreal, Quebec, H2L-1S6
Centre de Rhumatologie St. Louis
Québec, Quebec, G1W 4R4
About this study
Official title: A Cross-sectional Study to Explore the Osteoarthritis Structural Changes Assessed by MRI That Are Biomarkers of Neuropathic Pain in Knee Osteoarthritis
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).
Read the 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.
- Conditions
- Neuropathic Pain, Knee Osteoarthritis
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Neuropathic pain, Knee osteoarthritis, MRI
- Medical subject headings
- Neuralgia, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
All participants from both arms will be subjected to MRI
| Study group | Role | What they receive |
|---|---|---|
| With neuropathic pain (PainDETECT ≥ 13) | Magnetic Resonance Imaging (MRI) Receives: Other: Magnetic Resonance Imaging (MRI) | |
| No neuropathic pain (PainDETECT<13) | Magnetic Resonance Imaging (MRI) Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroLab Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Raynauld, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733277
- Sponsor's protocol ID
- A122-MER12H
- Status last verified
- May 2014
- First submitted
- 16 Nov 2012
- Last updated
- 2 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25497320
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study to Explore the Osteoarthritis Structural Changes Assessed by MRI That Are Biomarkers of Neuropathic Pain in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01733277
- Acronym / sponsor ID
- A122-MER12H
- Conditions
- Neuropathic Pain, Knee Osteoarthritis
- Keywords
- Neuropathic pain, Knee osteoarthritis, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ArthroLab Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With neuropathic pain (PainDETECT ≥ 13) | – | Other: Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) |
| No neuropathic pain (PainDETECT<13) | – | Other: Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Presence or absence of neuropathic pain on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm)
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)All participants from both arms will be subjected to MRI | Other | No neuropathic pain (PainDETECT<13), With neuropathic pain (PainDETECT ≥ 13) |
Primary outcome
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
Time frame: Baseline
1 secondary outcome
Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25497320Roubille 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Raynauld, MD principal investigator
Université de Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Knee Osteoarthritis, run by ArthroLab Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.