Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT05876858
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05876858
Study Brief:
Protocol Section:
NCT05876858