RECRUITING

EXPLORER Total Body PET/CT Imaging for Myofascial Pain

Conditions

Myofascial Pain total body positron emission tomography

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

EXPLORER Total Body PET/CT Imaging for Myofascial Pain

Quick Facts

Study Start:2023-06-13

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05876858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Lynda Painting, BS

CONTACT

916-731-9004

lpainting@ucdavis.edu

Dana Little, MS

CONTACT

916-734-7749

dalittle@ucdavis.edu

Principal Investigator

Lorenzo Nardo, MD

PRINCIPAL_INVESTIGATOR

University of California, Davis

Study Locations (Sites)

University of California Davis Health

Sacramento, California, 95826

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Lorenzo Nardo, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-13

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-06-13

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

total body positron emission tomography

Additional Relevant MeSH Terms

Myofascial Pain