PET Imaging of Chronic Pain Syndromes

Chronic Pain Syndrome Clinical Trial

Official title:

PET Imaging of Chronic Pain Syndromes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03233594
• Other study ID #: 17D.163
• Status: Active, not recruiting
• Start date: June 7, 2017
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Chiropractic Group
Participants will receive approximately 8 weeks of chiropractic care.
• Healthy Control Group
Participants will not receive any interventions.

Locations

Country	Name	City	State
United States	Thomas Jefferson University, Marcus Institute of Integrative Health Centers	Philadelphia	Pennsylvania
United States	Thomas Jefferson University, Marcus Institute of Integrative Health Centers	Villanova	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Pain Inventory Questionnaire	This validated questionnaire will be used as one of the evaluation questionnaires for the study.	Baseline and 8 weeks
Other	Numeric Rating Scale for Pain Intensity for specific locations	This validated questionnaire will be used as one of the evaluation questionnaires for the study.	Baseline and 8 weeks
Other	Profile of Mood Scale	The Profile of Mood States (POMS) is a validated questionnaire of 65 single word items that asks "How have you been feeling in the past week including today." The subjects will select their response to each word that describes a mood or feeling on a Likert scale from 1= Not at All, 2= A Little, 3=Moderately, 4=Quite a lot, to 5=Extremely. The responses are scored to generate values for Tension, Anger, Confusion, Depression and Vigor. The higher scores indicate a greater presence of that mood or state.	Baseline and 8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) for quality of life assessment	This validated questionnaire will be used as one of the evaluation questionnaires for the study.	Baseline and 8 weeks
Primary	Use combined PET/MRI to define pain activity pattern and inflammation.	To use PET-MRI to define abnormal brain and body activity and evaluate changes in inflammation in painful regions in patients with chronic pain syndromes.	Baseline and 8 weeks
Secondary	Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.	Patterns will be compared between those who respond and those who do not respond to chiropractic care.	Baseline and 8 weeks