EXPLORER Total Body PET/CT Imaging for Myofascial Pain

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)
• Treatments: Fluorodeoxyglucose F18

Criteria

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)