Back to resultsMR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
Primary Purpose
Chronic Low Back Pain, Diabetic Peripheral Neuropathy, Knee Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRIs
Pain testing
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Must be Right Handed.
(Chronic Pain with knee osteoarthritis)
- Diagnosed with: unilateral, symptomatic knee osteoarthritis based on American College of Rheumatology (ACR) criteria.
- Have had a knee x-ray within the last 6 months.
- Must have average pain intensity of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) scale.
(Chronic Low Back Pain)
- Have primary complaint of constant or intermittent back pain of at least 6 months duration.
- Have a Roland Morris Disability Questionnaire score of >7.
(Diabetes Mellitus with Painful Peripheral Neuropathy)
- Have a diagnosis of diabetes mellitus for at least 6 months.
- Have a diagnosis of diabetic peripheral neuropathy.
- Have had Electromyography(EMG) testing within the last 6 months.
- Have a >40 mm score on the short-form McGill Pain questionnaire.
(Healthy controls)
- Must be pain free
- No history of neurological or psychiatric illness.
- No diagnosis of Diabetes Mellitus.
- No evidence of neuropathy on clinical assessment.
Exclusion Criteria:
- Being pregnant.
- Have metal in the body or other contraindications to Magnetic Resonance Imaging (MRI).
- Have a chronic pain condition unrelated to knee osteoarthritis, chronic low back pain or diabetes.
- Have currently or a history of brain infection, stroke or tumor.
- Have a risk factor for other non-diabetic neuropathies
Sites / Locations
- VA Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
Knee osteoarthritis (MRI, surveys, pain testing)
Healthy controls (MRI, surveys,pain testing)
diabetic peripheral neuropathy
chronic low back pain
Arm Description
Subjects previously diagnosed with knee osteoarthritis will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Healthy volunteers will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Subjects previously diagnosed with diabetic peripheral neuropathy will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Subjects previously diagnosed with chronic low back pain will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Outcomes
Primary Outcome Measures
Assessment of chronic pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01620775
Brief Title
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
Official Title
MR (Magnetic Resonance) Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator was unable to fulfill his responsibilities.
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 7, 2017 (Actual)
Study Completion Date
June 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to assess:
Hypothesis #1: That there is a significant central pain component in a distinct subset of patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful diabetic neuropathy(PDN.)
Hypothesis # 2: To establish a reliable strategy for differentiation of central pain predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features, experimental pain testing and magnetic resonance(MR) Spectroscopy.
Detailed Description
This study will identify clinical and neuroimaging markers in chronic pain in an effort to provide individual-based treatments. This study will differentiate chronic pain subjects (knee osteoarthritis, low back pain and painful diabetic neuropathy) into two groups: those who have central pain predominant symptoms and those who have peripheral pain predominant symptoms. The response to medical treatment between these two groups is quite different, thus a reliable strategy to correctly categorize chronic pain sufferers offers the opportunity to provide targeted, effective treatments. Chronic pain is a prevalent problem in the VA veteran population with significant associated costs; in particular knee osteoarthritis, chronic low back pain and painful diabetic neuropathy are common in this population. The proposed study will use different clinical pain tests and advanced neuroimaging techniques to improve our understanding of chronic pain and improve patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Diabetic Peripheral Neuropathy, Knee Osteoarthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knee osteoarthritis (MRI, surveys, pain testing)
Arm Type
Experimental
Arm Description
Subjects previously diagnosed with knee osteoarthritis will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Arm Title
Healthy controls (MRI, surveys,pain testing)
Arm Type
Active Comparator
Arm Description
Healthy volunteers will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Arm Title
diabetic peripheral neuropathy
Arm Type
Experimental
Arm Description
Subjects previously diagnosed with diabetic peripheral neuropathy will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Arm Title
chronic low back pain
Arm Type
Experimental
Arm Description
Subjects previously diagnosed with chronic low back pain will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing.
Intervention Type
Other
Intervention Name(s)
MRIs
Intervention Description
Subjects will have an MRI scan to view specific images, and brain activity patterns thought to be affected in patients with KOA, chronic low back pain and diabetic patients with painful neuropathy. Healthy volunteers will undergo the same MRI scan that lasts about 90 min.
Intervention Type
Other
Intervention Name(s)
Pain testing
Intervention Description
There will be a 1-1.5 hour session including pain tolerance testing.
Primary Outcome Measure Information:
Title
Assessment of chronic pain
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Must be Right Handed.
(Chronic Pain with knee osteoarthritis)
Diagnosed with: unilateral, symptomatic knee osteoarthritis based on American College of Rheumatology (ACR) criteria.
Have had a knee x-ray within the last 6 months.
Must have average pain intensity of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) scale.
(Chronic Low Back Pain)
Have primary complaint of constant or intermittent back pain of at least 6 months duration.
Have a Roland Morris Disability Questionnaire score of >7.
(Diabetes Mellitus with Painful Peripheral Neuropathy)
Have a diagnosis of diabetes mellitus for at least 6 months.
Have a diagnosis of diabetic peripheral neuropathy.
Have had Electromyography(EMG) testing within the last 6 months.
Have a >40 mm score on the short-form McGill Pain questionnaire.
(Healthy controls)
Must be pain free
No history of neurological or psychiatric illness.
No diagnosis of Diabetes Mellitus.
No evidence of neuropathy on clinical assessment.
Exclusion Criteria:
Being pregnant.
Have metal in the body or other contraindications to Magnetic Resonance Imaging (MRI).
Have a chronic pain condition unrelated to knee osteoarthritis, chronic low back pain or diabetes.
Have currently or a history of brain infection, stroke or tumor.
Have a risk factor for other non-diabetic neuropathies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Foerster Bradley, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Foerster, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
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