Total Body PET/CT Imaging for Myofascial Pain
EXPLORER Total Body PET/CT Imaging for Myofascial Pain
This study is testing a new imaging technique to see if it can help understand and improve treatment for people with chronic low back pain caused by myofascial pain.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05876858 on ClinicalTrials.gov |
What this trial studies
This study aims to establish new quantitative biomarkers for myofascial pain using Total-body Positron Emission Tomography/Computed Tomography (TB-PET/CT). It focuses on assessing myofascial tissue metabolism, perfusion, and fatty infiltration in patients with chronic low back pain. Participants will undergo two different scans, one lasting 60-70 minutes and another lasting 10-20 minutes, to gather data on their condition. The study seeks to improve understanding and treatment of myofascial pain syndrome, which significantly impacts patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic low back pain lasting at least three months and specific palpable muscle nodules.
Not a fit: Patients without a primary care physician or those with a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and evidence-based treatments for myofascial pain.
How similar studies have performed: While this approach is innovative, similar studies using imaging techniques for pain assessment have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sacramento, California
- University of California Davis Health — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Lorenzo Nardo, MD — University of California, Davis
- Study coordinator: Dana Little, MS
- Email: dalittle@ucdavis.edu
- Phone: 916-734-7749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.