Chronic Pain SyndromeNCT03233594
PET Imaging of Chronic Pain Syndromes
An observational study of Chronic Pain Syndrome, run by Thomas Jefferson University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- Chiropractic Group
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2017to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited only if they are already planning on receiving standard clinical chiropractic care for their pain.
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Villanova, Pennsylvania, 19085
About this study
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.
Read the 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.
- Conditions
- Chronic Pain Syndrome
- Being tested
- Chiropractic Group, Healthy Control Group
- Keywords
- Chronic Pain Syndrome, Chronic Pain, Chiropractic, PET, MRI, Positron emission tomography, Magnetic resonance imaging, Neuro Emotive Technique (NET)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic GroupOther
Participants will receive approximately 8 weeks of chiropractic care.
Healthy Control GroupOther
Participants will not receive any interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chiropractic Group | |
| Healthy Control Group | Participants will receive initial evaluations and questionnaires followed by a PET-MRI scan. Receives: Other: Healthy Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start7 Jun 2017
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B. Newberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233594
- Sponsor's protocol ID
- 17D.163
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2017
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Chronic Pain Syndromes
- ClinicalTrials.gov ID
- NCT03233594
- Acronym / sponsor ID
- 17D.163
- Conditions
- Chronic Pain Syndrome
- Keywords
- Chronic Pain Syndrome, Chronic Pain, Chiropractic, PET, MRI, Positron emission tomography, Magnetic resonance imaging, Neuro Emotive Technique (NET)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Group | – | Other: Chiropractic GroupParticipants 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 | – | Other: Healthy Control GroupParticipants will receive initial evaluations and questionnaires followed by a PET-MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited only if they are already planning on receiving standard clinical chiropractic care for their pain.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic GroupParticipants will receive approximately 8 weeks of chiropractic care. | Other | Chiropractic Group |
| Healthy Control GroupParticipants will not receive any interventions. | Other | Healthy Control Group |
Primary outcome
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.
1 secondary outcome
Use combined PET/MRI to demonstrate brain and body activity in responders and non-responders.
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew B. Newberg, MD principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Syndrome, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use combined PET/MRI to define pain activity pattern and inflammation. (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.