PET Imaging of Chronic Pain Syndromes

Sponsor
Thomas Jefferson University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03233594
Collaborator
(none)
32
2
81.8
16
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chiropractic Group
  • Other: Healthy Control Group

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
PET Imaging of Chronic Pain Syndromes
Actual Study Start Date :
Jun 7, 2017
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Participants will receive approximately 8 weeks of chiropractic care.

Healthy Control Group

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

Other: Healthy Control Group
Participants will not receive any interventions.

Outcome Measures

Primary Outcome Measures

  1. Use combined PET/MRI to define pain activity pattern and inflammation. [Baseline and 8 weeks]

    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.

Secondary Outcome Measures

  1. Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders. [Baseline and 8 weeks]

    Patterns will be compared between those who respond and those who do not respond to chiropractic care.

Other Outcome Measures

  1. Brief Pain Inventory Questionnaire [Baseline and 8 weeks]

    This validated questionnaire will be used as one of the evaluation questionnaires for the study.

  2. Numeric Rating Scale for Pain Intensity for specific locations [Baseline and 8 weeks]

    This validated questionnaire will be used as one of the evaluation questionnaires for the study.

  3. Profile of Mood Scale [Baseline and 8 weeks]

    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.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) for quality of life assessment [Baseline and 8 weeks]

    This validated questionnaire will be used as one of the evaluation questionnaires for the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University, Marcus Institute of Integrative Health Centers Philadelphia Pennsylvania United States 19107
2 Thomas Jefferson University, Marcus Institute of Integrative Health Centers Villanova Pennsylvania United States 19085

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

  • Principal Investigator: Andrew B. Newberg, MD, Thomas Jefferson University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT03233594
Other Study ID Numbers:
  • 17D.163
First Posted:
Jul 28, 2017
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Jefferson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022