Clinical trial NCT03233594: PET Imaging of Chronic Pain Syndromes
Official title: PET Imaging of Chronic Pain Syndromes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain Syndrome
Keywords: Chronic Pain Syndrome
Chronic Pain
Chiropractic
PET
MRI
Positron emission tomography
Magnetic resonance imaging
Neuro Emotive Technique (NET)
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited only if they are already planning on receiving standard clinical chiropractic care for their pain.

Brief summary: Central nervous system (CNS) changes associated with pain have been difficult to measure until the development of functional neuroimaging techniques such as positron emission tomography (PET). We have previously observed asymmetry in the thalamus associated with chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic techniques for chronic pain in animals and humans have been quite limited. This study will be the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS changes and peripheral body changes related to chronic pain and its potential management.

Detailed description: The proposed study is based on our growing understanding of chronic pain and our ability to use functional brain imaging to study in vivo neurophysiologic processes. It is important to understand the brain and body mechanisms of chronic pain in order to better determine therapeutic interventions to reduce pain. Part of the difficulty in treating chronic pain is to determine how better to diagnose what specific issues are affecting the brain and body that result in chronic pain. Participants will undergo a small battery of diagnostic tests that include magnetic resonance imaging (MRI), positron emission tomography (PET). A secondary goal of this study is to determine if undergoing chiropractic care alters body or brain physiology in patients with chronic pain.

Eligibility criteria: Inclusion Criteria for Chronic Pain Patients:

* Age greater than 18 years old.
* Have chronic pain symptoms for \>3 months;
* Have moderate pain (\>3/10) in 2 or more areas for more than 5 out of 7 days
* Is planning on undergoing chiropractic care for the clinical management of the chronic pain.
* May be on pain medications provided that they are on a stable dose for at least 1 month
* Patients have no other pre-existing and active significant medical, neurological, or psychological disorders.
* Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
* Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
* Able to give informed consent and willing to complete the study at Thomas Jefferson University and Marcus Institute of Integrative Health.

Inclusion Criteria for Healthy Controls:

* No significant current active medical conditions.
* Stable medical conditions as determined by the PI are allowed.
* No brain or body abnormalities that would affect the acquisition or analysis of the scan.

Exclusion Criteria for Chronic Pain Patients and Healthy Controls:

* Pregnant or breast feeding
* Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
* Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight)
* Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.

Primary outcomes:
measure: Use combined PET/MRI to define pain activity pattern and inflammation.
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Brief Pain Inventory Questionnaire
timeFrame: Baseline and 8 weeks
measure: Numeric Rating Scale for Pain Intensity for specific locations
timeFrame: Baseline and 8 weeks
measure: Profile of Mood Scale
timeFrame: Baseline and 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) for quality of life assessment
timeFrame: Baseline and 8 weeks
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Marcus Institute of Integrative Health Centers
state: Pennsylvania
city: Villanova
country: United States
facility: Thomas Jefferson University, Marcus Institute of Integrative Health Centers
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Andrew B. Newberg, MD
role: PRINCIPAL_INVESTIGATOR
References: