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Active Not Recruiting
NCT05876858
EXPLORER Total Body PET/CT Imaging for Myofascial Pain
Conditions: Myofascial Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 53
Sponsor: University of California, Davis
Location: University of California Davis Health Sacramento California
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.
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\
Source: ClinicalTrials.gov (NCT05876858). StuddyBuddy aggregates publicly available trial information.