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Total Body PET/CT Imaging for Myofascial Pain
Phase < 1
Recruiting
Led By Lorenzo Nardo, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; up to 30 minutes (30 min being the time to fil out questionnaires)
Awards & highlights
Study Summary
This trial aims to use advanced imaging to measure biomarkers for myofascial pain, assessing tissue metabolism, perfusion, and fatty infiltration.
Who is the study for?
Adults over 18 with chronic low back pain for the past 3 months, experiencing pain more than half of the days in the last six months. Participants must have a palpable muscle nodule or taut band and be able to lay still for scans after fasting. Exclusions include pregnant individuals, those over 240 kg, people with certain medical conditions like cancer or spine issues, and anyone who can't consent in English.Check my eligibility
What is being tested?
The trial is testing TB-PET/CT imaging using two tracers (11C-butanol and 18F-FDG) to identify biomarkers for myofascial pain by measuring tissue metabolism, perfusion, and fatty infiltration. Participants will undergo two separate scans on different occasions while fasting.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans, reactions to tracers such as mild allergic responses or slight radiation exposure risks associated with PET/CT imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this is a cross-sectional study and the peg score will be evaluated at baseline on the day of the scans.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this is a cross-sectional study and the peg score will be evaluated at baseline on the day of the scans.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differentiate Myofascial tissues
HEAL outcome measure
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET/CT scansExperimental Treatment2 Interventions
Each subject will undergo a dynamic 18F-FDG PET/CT scan and a dynamic 11C-butanol PET/CT scan on the EXPLORER total-body PET/CT system
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-FDG
2010
Completed Phase 2
~660
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,466 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,797 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of certain autoimmune or connective tissue diseases.I have had cancer before, but not skin cancer.I have pain in my hip due to arthritis.I experience pain below my knee.I have had a spinal fracture in the past 6 months.My main pain is deep within my body.I am 18 years old or older.I have had chronic low back pain for the past 3 months, with pain on most days in the last 6 months.I have weakness in my legs due to a spine or nerve condition.I feel anxious or uneasy in tight spaces.I can fast for at least 6 hours before and during the scan.My pain is mostly in the middle of my body, and it can be on one or both sides.I can stay still on my back for up to 70 minutes.My main pain is triggered when a tight muscle area is pressed.I have conditions known to cause pain.I have had a spine infection or tumor in the past.I have at least one noticeable lump or tight band in my back or buttock muscles.
Research Study Groups:
This trial has the following groups:- Group 1: PET/CT scans
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available opportunities to participate in this research?
"As evidenced on clinicaltrials.gov, this experiment is actively looking for participants; the initial post was made on June 13th 2023 and the latest update occurred July 29th of that same year."
Answered by AI
What is the current enrollment size of this experiment?
"Affirmative. The clinicaltrials.gov registry implies that this project is currently enrolling participants; the trial was first made visible on June 13th 2023 and was recently revised on July 29th 2023. Only 53 persons will be included in this study, which will take place at a single medical site."
Answered by AI
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