EXPLORER Total Body PET/CT Imaging for Myofascial Pain

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial, called EXPLORER, is investigating a new imaging technique called Total Body PET/CT to better understand myofascial pain, which is a type of chronic pain often linked to muscle knots and tension. Researchers aim to identify specific measures from these scans that can help in assessing how myofascial tissues are functioning. If you're experiencing chronic low back pain for at least three months and have muscle knots that reproduce your pain when pressed, you might be eligible to participate in this study.

Participants in the trial will undergo two imaging scans while lying still for about 60-70 minutes and 10-20 minutes, respectively. Before the scans, you’ll need to fast for at least six hours and avoid vigorous exercise for a day. The study is open to both men and women aged 18 and older, but it's important to note that certain health conditions or recent medical history could make you ineligible. If you’re interested and meet the criteria, you’ll be helping researchers find better ways to diagnose and understand myofascial pain.

Gender

ALL

Eligibility 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)