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PET Imaging of Chronic Pain Syndromes

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ClinicalTrials.gov Identifier: NCT03233594
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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
Chronic Pain Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PET Imaging of Chronic Pain Syndromes
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : June 6, 2020
Estimated Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chiropractic Group
Participants receiving chiropractic care 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.




Primary Outcome Measures :
  1. Use combined PET/MRI to define pain activity pattern and inflammation. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 8 weeks ]
    This validated questionnaire will be used as one of the evaluation questionnaires for the study.

  3. Profile of Mood Scale [ Time Frame: 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 [ Time Frame: Baseline and 8 weeks ]
    This validated questionnaire will be used as one of the evaluation questionnaires for the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233594


Locations
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United States, Pennsylvania
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, United States, 19085
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Andrew B. Newberg, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03233594     History of Changes
Other Study ID Numbers: 17D.163
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Jefferson University:
Chronic Pain Syndrome
Chronic Pain
Chiropractic
PET
MRI
Positron emission tomography
Magnetic resonance imaging

Additional relevant MeSH terms:
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Syndrome
Chronic Pain
Somatoform Disorders
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders