MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain

NCT ID: NCT01620775

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-06-07

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.

Conditions

Chronic Low Back Pain; Diabetic Peripheral Neuropathy; Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRIs

Intervention Type: OTHER

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.

Pain testing

Intervention Type: OTHER

There will be a 1-1.5 hour session including pain tolerance testing.

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.

Group Type: ACTIVE_COMPARATOR

MRIs

Intervention Type: OTHER

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.

Pain testing

Intervention Type: OTHER

There will be a 1-1.5 hour session including pain tolerance testing.

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.

Group Type: EXPERIMENTAL

MRIs

Intervention Type: OTHER

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.

Pain testing

Intervention Type: OTHER

There will be a 1-1.5 hour session including pain tolerance testing.

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.

Group Type: EXPERIMENTAL

MRIs

Intervention Type: OTHER

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.

Pain testing

Intervention Type: OTHER

There will be a 1-1.5 hour session including pain tolerance testing.

Interventions

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.

Intervention Type: OTHER

Pain testing

There will be a 1-1.5 hour session including pain tolerance testing.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Foerster Bradley, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Bradley Foerster, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

VA Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00055261

Identifier Type: -

Identifier Source: org_study_id