PET Imaging of Chronic Pain Syndromes

NCT03233594 | Active Not Recruiting

• 1 other identifier: 17D.163
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain Syndrome

Keywords

Chronic Pain Syndrome; Chronic Pain; Chiropractic; PET; MRI; Positron emission tomography; Magnetic resonance imaging; Neuro Emotive Technique (NET)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.

  Baseline and 8 weeks

Other Outcomes (4)

• Brief Pain Inventory Questionnaire

  Baseline and 8 weeks

• Numeric Rating Scale for Pain Intensity for specific locations

  Baseline and 8 weeks

• Profile of Mood Scale

  Baseline and 8 weeks

Study Arms (2)

Chiropractic Group

Participants receiving a chiropractic care technique Neuro Emotive Technique (NET) will complete initial pain evaluations and questionnaires for chronic pain symptoms. After approximately 8 weeks participants will receive follow evaluation for pain. Pre and Post PET-MRI scan will be conducted to evaluate changes.

Other: Chiropractic Group

Healthy Control Group

Participants will receive initial evaluations and questionnaires followed by a PET-MRI scan.

Other: Healthy Control Group

Interventions

Chiropractic Group OTHER

Participants will receive approximately 8 weeks of chiropractic care.

Chiropractic Group

Healthy Control Group OTHER

Participants will not receive any interventions.

Healthy Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Villanova, Pennsylvania, 19085, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew B. Newberg, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 28, 2017
• Study Start: June 7, 2017
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)