MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Bradley Foerster M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01620775
First received: June 13, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Diabetic Peripheral Neuropathy
Knee Osteoarthritis
Procedure: MRI (Magnetic Resonance Imaging)
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: MR (Magnetic Resonance) Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Assessment of chronic pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chronic Pain
Subjects who have been diagnosed with Diabetic peripheral neuropathy (DPN), Symptomatic knee osteoarthritis, chronic low back pain
Procedure: MRI (Magnetic Resonance Imaging)
Subjects will undergo (2) MRI scans 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. The MRI scan will take approximately hour to complete. An MRI will be completed in the morning and one in the afternoon.
Active Comparator: Healthy controls
Healthy volunteers will undergo an MRI so that images of brain metabolites can be assessed and compared to those metabolites in patients with chronic pain conditions.
Procedure: MRI
Subjects designated as Healthy volunteers will undergo (2) MRIs that will take approximately 1 hour each to complete. One MRI will be completed in the morning and one in the afternoon.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

Are 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 A BRAIN INFECTION,STROKE OR TUMOR. Have a history of migraines, traumatic brain injury or seizure. HAVE RISK FACTORS FOR OTHER NON-DIABETIC(not diabetic) NEUROPATHIES

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620775

Contacts
Contact: Bradley Foerster, M.D. (734) 615-3586 compfun@umich.edu

Locations
United States, Michigan
VA Hospital Recruiting
Ann Arbor, Michigan, United States
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Foerster Bradley, M.D. University of Michigan
Principal Investigator: Bradley Foerster, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Bradley Foerster M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01620775     History of Changes
Other Study ID Numbers: HUM00055261
Study First Received: June 13, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Low Back Pain
Peripheral Nervous System Diseases
Osteoarthritis, Knee
Osteoarthritis
Chronic Pain
Diabetic Neuropathies
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014