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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Healthy Control Group | Participants will receive initial evaluations and questionnaires followed by a PET-MRI scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Group | Other | Participants will receive approximately 8 weeks of chiropractic care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory Questionnaire | This validated questionnaire will be used as one of the evaluation questionnaires for the study. | Baseline and 8 weeks |
| Numeric Rating Scale for Pain Intensity for specific locations |
Inclusion Criteria for Chronic Pain Patients:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Chronic Pain Patients and Healthy Controls:
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Subjects will be recruited only if they are already planning on receiving standard clinical chiropractic care for their pain.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew B. Newberg, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University, Marcus Institute of Integrative Health Centers | Philadelphia | Pennsylvania | 19107 | United States | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2020 | Nov 24, 2021 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Healthy Control Group | Other | Participants will not receive any interventions. |
|
This validated questionnaire will be used as one of the evaluation questionnaires for the study.
| Baseline and 8 weeks |
| 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 |
| 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 |
| Thomas Jefferson University, Marcus Institute of Integrative Health Centers |
| Villanova |
| Pennsylvania |
| 19085 |
| United States |