Myofascial Pain Clinical Trial
Official title:
EXPLORER Total Body PET/CT Imaging for Myofascial Pain
The main objective of this study is to establish novel measures derived from Total-body-Positron Emission Tomography/Computed Tomography (TB-PET/CT) as quantitative biomarkers for the investigation of myofascial pain. The TB-PET/CT assessed measures are those reflective of myofascial tissue metabolism, perfusion, and fatty infiltration.
Status | Recruiting |
Enrollment | 53 |
Est. completion date | September 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand and willingness to sign an informed consent form - Ability to adhere to the study visit schedule and all protocol requirements. - Men and women =18 years of age - Current self-report of chronic low back pain (cLBP) which has persisted for the past 3 months AND has resulted in pain on > 50% of days in the past 6 months - At least one palpable nodule or taut band in paraspinal, quadratus lumborum, or gluteal muscles - Reproduction of the patient's dominant pain with palpation of a muscle nodule or taut band - Predominantly paramedian pain (may be uni-lateral or bi-lateral) - Willing and able to lay motionless in a supine position on 2 different occasions: - 60-70 minutes 18F-FDG scan - 10-20 minutes 11C-Butanol Scan - Willing and able to fast for at least 6 hours before and for the duration of the scan - Willing to avoid strenuous exercise for 24 hours before the scan visit Exclusion Criteria: - No Primary Care Physician - History of any cancer (except non-melanoma skin cancer) - History of spine infection (discitis or osteomyelitis) or spine tumor - History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus or other connective tissue diseases. - Confounding conditions that are known to be responsible for inducing pain - Implants at or in the region of the sites of interest - Diagnosis of any vertebral fracture in the last 6 months - Cauda equina syndrome or lumbar radiculopathy with functional motor deficit (strength<4/5 on manual motor testing) - Spinal implants (including fixation hardware, spinal cord stimulator, intra-thecal pumps) - Predominantly central pain - Pain below the knee - Positive straight leg raise test - Symptomatic hip arthritis - Fasting blood glucose level greater than 200 mg/dl before administration of 18F-FDG - Self-reported history of dysphoria or anxiety in closed spaces - Pregnant or lactating subjects - Body weight more than 240 kg (529 pounds) due to the weight limitation of the scanner bed - Prisoners - Inability to speak, read, and write in the English language - Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only - Any other criteria, which would make the subject unsuitable to participate in this study as determined by the Principal Investigator (e.g., subject has a Legally Authorized Representative and cannot consent for him/herself) |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Health | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HEAL outcome measure | Our primary outcome measure is the NIH Helping to End Addiction Long-term (HEAL) measure: PEG (Pain, Enjoyment, General Activity) score, which quantitatively evaluates pain intensity and interference. This is a score from 0 to 10. | This is a cross-sectional study and the PEG score will be evaluated at baseline on the day of the scans. | |
Primary | Differentiate Myofascial tissues | The primary outcome measure is the Standardized Uptake Value (SUV) derived from the Positron Emission Tomography scans. This is a unitless quantity. | Baseline; Up to 30 minutes (30 min being the time to fil out questionnaires) |
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