FDG PET/MRI Evaluation of Facet Joint Pain

NCT02921490 | Completed Results

• 1 other identifier: 15-001228
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost wages, etc) annually. The most common source is low back pain (LBP), often from facet joints. The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can cost thousands of dollars per session and delay diagnoses. Very limited retrospective information suggests that high grade peri-facet MRI signal change correlates to the side of LBP. However, this has not fully characterized the imaging findings and has not correlated to expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact. Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams, but the evidence of correlation to patient pain is lacking. Limited DWI exists for inflammatory spondyloarthropathies and myopathies, but is also lacking. This is an exploratory study investigating the utility of FDG PET activity and MRI signal change around facet joints in the clinical management of low back pain. This study will help determine if such imaging biomarkers could change clinical management. Additionally, this will provide data that will be vital to planning a larger prospective study evaluating the ability of imaging biomarkers to predict response to comparison medial branch blocks and RF ablation for treatment of facet joint pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (8)

• Facet Joint High Grade FDG Activity Concordance to Pain

  Concordance of high grade FDG scores with clinical impression

  2 years

• Facet Joint All Grades of FDG Activity Concordance to Pain

  Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

  2 years

• Facet Joint High Grade MRI Signal Change Concordance to Pain

  Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

  2 years

• Facet Joint Any Grade of MRI Signal Change Concordance to Pain

  Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression

  2 years

• Facet Joint High Grade FDG Activity Potential Effect on Management

  Number/percentage of subjects for whom high grade FDG scores would change clinical management

  2 years

• Facet Joint All Grades of FDG Activity Potential Effect on Management

  Number/percentage of subjects for whom any grade FDG scores would change clinical management

  2 years

• Facet Joint High Grade MRI Signal Change Potential Effect on Management

  Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management

  2 years

• Facet Joint Any Grade MRI Signal Change Potential Effect on Management

  Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management

  2 years

Study Arms (1)

PET/MR recipients

EXPERIMENTAL

All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.

Device: FDG PET/MR examination.

Interventions

FDG PET/MR examination. DEVICE

All recruited patients will undergo an FDG PET examination focused on the lumbar spine.

PET/MR recipients

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients over the age of 50-100 years with clinically suspected facetogenic low back pain.
• Patients must be considered to have at least a 60% chance of having facet joints as the major source of low back pain based on overall clinical impression.
• All patients will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain.
• Patients with either unilateral or bilateral axial low back pain may be enrolled.

You may not qualify if:

• Pregnancy
• Prior lumbar back surgery
• History of endovascular repair of abdominal aortic aneurysm or other postoperative change likely to introduce imaging artifact to the lumbar spine
• Suspected spine infection
• Known osseous metastatic or other osseous malignancy
• Facet joint percutaneous treatment within the past 2 months
• History of major lumbar spine trauma
• Inability to provide own consent
• Claustrophobia, cardiac pacemaker/wires in place, any absolute contraindication to MRI
• Impaired renal function indicated by a GFR less than 30
• Gadolinium allergy
• Highly radiosensitive medical conditions
• Patients who are unable to lay quietly for 60 minutes of imaging

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vance Lehman
• Organization: Mayo Clinic

lehman.vance@mayo.edu

1-507-284-2511

Study Officials

• Vance T Lehman

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. , Assistant Professor of Radiology

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: October 1, 2019
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)