MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain

NCT01620775 | Terminated DMC

• 1 other identifier: HUM00055261
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Diabetic Peripheral Neuropathy; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Assessment of chronic pain

  2 years

Study Arms (4)

Knee osteoarthritis (MRI, surveys, pain testing)

EXPERIMENTAL

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; Other: Pain testing

Healthy controls (MRI, surveys,pain testing)

ACTIVE COMPARATOR

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; Other: Pain testing

diabetic peripheral neuropathy

EXPERIMENTAL

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; Other: Pain testing

chronic low back pain

EXPERIMENTAL

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; Other: Pain testing

Interventions

MRIs 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.

Healthy controls (MRI, surveys,pain testing); Knee osteoarthritis (MRI, surveys, pain testing); chronic low back pain; diabetic peripheral neuropathy

Pain testing OTHER

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

Healthy controls (MRI, surveys,pain testing); Knee osteoarthritis (MRI, surveys, pain testing); chronic low back pain; diabetic peripheral neuropathy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

VA Hospital

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Foerster Bradley, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Bradley Foerster, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: September 1, 2012
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)