MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain

MR (Magnetic Resonance) Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain

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.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis; Chronic Low Back Pain; Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: MRIs; Other: Pain testing

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knee osteoarthritis (MRI, surveys, pain testing); 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.	Other: MRIs; 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.; Other: Pain testing; There will be a 1-1.5 hour session including pain tolerance testing.
Active Comparator: Healthy controls (MRI, surveys,pain 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.	Other: MRIs; 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.; Other: Pain testing; There will be a 1-1.5 hour session including pain tolerance testing.
Experimental: diabetic peripheral neuropathy; 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.	Other: MRIs; 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.; Other: Pain testing; There will be a 1-1.5 hour session including pain tolerance testing.
Experimental: chronic low back pain; 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.	Other: MRIs; 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.; Other: Pain testing; There will be a 1-1.5 hour session including pain tolerance testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of chronic pain	2 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Foerster Bradley, M.D., University of Michigan; Principal Investigator: Bradley Foerster, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): June 7, 2017

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Diseases; Osteoarthritis; Back Pain; Low Back Pain; Osteoarthritis, Knee; Chronic Pain; Peripheral Nervous System Diseases
• Other Study ID Numbers: HUM00055261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No