53 Participants Needed

Total Body PET/CT Imaging for Myofascial Pain

LP
DL
LN
Overseen ByLorenzo Nardo, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the drug 11C-butanol and 18F-FDG for treating myofascial pain?

The research shows that 18F-FDG PET/CT imaging can detect metabolic activity related to pain in the spinal cord, which may help in understanding pain conditions like myofascial pain. Additionally, 18F-FDG has been used to identify inflammation in low back pain, suggesting its potential usefulness in assessing pain-related conditions.12345

Is 11C-butanol safe for use in humans?

11C-butanol has been used in studies to image blood flow in animals, and it was produced as a sterile, pyrogen-free solution meeting safety standards. However, specific human safety data is not provided in the available research.678910

How does the treatment in the Total Body PET/CT Imaging for Myofascial Pain trial differ from other treatments for this condition?

This treatment is unique because it uses total body PET/CT imaging to detect metabolic activity related to pain, which can help identify specific areas of pain in the body. Unlike traditional treatments that focus on symptom relief, this approach aims to understand the underlying metabolic changes associated with myofascial pain.12111213

What is the purpose of this trial?

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.

Research Team

LN

Lorenzo Nardo, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

Inclusion Criteria

I have had chronic low back pain for the past 3 months, with pain on most days in the last 6 months.
Ability to understand and willingness to sign an informed consent form
I can fast for at least 6 hours before and during the scan.
See 6 more

Exclusion Criteria

Implants at or in the region of the sites of interest
Positive straight leg raise test
Fasting blood glucose level greater than 200 mg/dl before administration of 18F-FDG
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo dynamic 18F-FDG PET/CT and 11C-butanol PET/CT scans on the EXPLORER total-body PET/CT system

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

  • 11C-butanol
  • 18F-FDG
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Findings from Research

In a study involving 6 patients with low back pain, dynamic [18F]-sodium fluoride PET/MR imaging showed a significant positive correlation between the uptake rate in facet joints and the level of clinical disability, indicating that higher uptake is associated with greater disability.
These findings suggest that [18F]-NaF PET imaging could be a valuable biomarker for assessing disability related to facetogenic low back pain, potentially aiding in diagnosis and treatment planning.
[18F]-Sodium Fluoride PET MR-Based Localization and Quantification of Bone Turnover as a Biomarker for Facet Joint-Induced Disability.Jenkins, NW., Talbott, JF., Shah, V., et al.[2018]
Patients with low back pain (LBP) showed significantly higher metabolic activity in the thoracic spinal cord, as measured by 18F-FDG PET/CT, compared to those without LBP, particularly at spinal nerves T7 to T10.
This study suggests that 18F-FDG PET/CT could serve as a useful biomarker for identifying active pain-related regions in the spinal cord, potentially guiding targeted treatments for LBP.
Detection of nociceptive-related metabolic activity in the spinal cord of low back pain patients using 18F-FDG PET/CT.Zhou, X., Cipriano, P., Kim, B., et al.[2021]
In a study involving 22 participants (12 pain-free controls and 12 individuals with low back pain), PET/CT imaging revealed that those with low back pain had higher levels of inflammation and microcalcification in their lumbar spine, suggesting these factors may contribute to their pain.
The use of AI-based quantification in analyzing PET/CT scans proved effective, indicating that this method could help identify nociceptive sources of low back pain and should be explored further.
PET/CT imaging of spinal inflammation and microcalcification in patients with low back pain: A pilot study on the quantification by artificial intelligence-based segmentation.Piri, R., Nøddeskou-Fink, AH., Gerke, O., et al.[2022]

References

[18F]-Sodium Fluoride PET MR-Based Localization and Quantification of Bone Turnover as a Biomarker for Facet Joint-Induced Disability. [2018]
Detection of nociceptive-related metabolic activity in the spinal cord of low back pain patients using 18F-FDG PET/CT. [2021]
PET/CT imaging of spinal inflammation and microcalcification in patients with low back pain: A pilot study on the quantification by artificial intelligence-based segmentation. [2022]
Assessment of Myofascial Trigger Points via Imaging: A Systematic Review. [2023]
Cingulate GABA levels inversely correlate with the intensity of ongoing chronic knee osteoarthritis pain. [2020]
Efficient radiosynthesis and non-clinical safety tests of the TSPO radioprobe [(18)F]FEDAC: Prerequisites for clinical application. [2018]
The total body mass of fatty acid ethyl esters in skeletal muscles following ethanol exposure greatly exceeds that found in the liver and the heart. [2013]
11C-butanol for imaging of the blood-flow distribution in tumor-bearing animals. [2019]
[18F]fluoroacetate positron emission tomography for hepatocellular carcinoma and metastases: an alternative tracer for [11C]acetate? [2016]
Synthesis of [1-11C]Butanol via a facile solid phase extraction protocol. [2020]
[Determination of regional rate of glucose metabolism in lumbar muscles in patients with generalized tendomyopathy using dynamic 18F-FDG PET]. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Positron emission tomography in patients with fibromyalgia syndrome and healthy controls. [2016]
PET/CT imaging in polymyalgia rheumatica: praepubic 18F-FDG uptake correlates with pectineus and adductor longus muscles enthesitis and with tenosynovitis. [2019]
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