Clinical trial NCT01620775: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low Back Pain
Diabetic Peripheral Neuropathy
Knee Osteoarthritis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Assessment of chronic pain
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Foerster Bradley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Bradley Foerster, M.D.
role: PRINCIPAL_INVESTIGATOR
References: