Neck PainNCT02356315
Brain, Brainstem, and Spinal Cord fMRI
An observational study of Neck Pain and Chronic Pain, run by Northwestern University at 1 site in United States.
Trial summary
New advances in medical imaging have allowed for the measurement of brain activity related to chronic pain. In addition to the brain, the investigators aim to use functional magnetic resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy subjects and chronic neck pain patients. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Functional Magnetic Resonance Imaging
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects and chronic neck pain patients recruited from the community
Healthy subjects must meet all of the following inclusion criteria to participate in this study:
- Age between 21 and 60 years old
- Right-handed; not currently experiencing significant pain
- No history of a chronic pain syndrome such as fibromyalgia, complex regional pain syndrome, chronic low back pain, etc.
Chronic neck pain patients must meet all of the following inclusion criteria to participate in this study:
- Age between 21 and 60 years old
- Right handed; neck pain > 3 months duration; moderate neck pain score > 30 on VAS (0-100) 3) No history of a chronic pain syndrome (fibromyalgia, complex regional pain syndrome, chronic low back pain, etc.) other than chronic neck pain and its associated symptoms.
Participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Non-English speaking
- Signs of upper extremity sensation loss; history of significant cerebrovascular disease including (but not limited to) epilepsy, stroke, tumor, multiple sclerosis, meningitis
- History of major head trauma with sustained loss of consciousness; history of neurosurgery, ENT surgery, spine surgery, or cardiac surgery
- History of cardiac pacemaker or neurostimulator implantation
- History of significant medical illness including cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, etc.
- History of alcoholism or consistent drug use; current infection or fever; pregnancy (or possible pregnancy)
- History of metal working or injury with shrapnel or metal slivers
- Claustrophobia
- Piercings that are unable to be removed and tattoos older than 30 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Translational Imaging, Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI
New advances in medical imaging have allowed for the measurement of brain activity related to chronic pain. In addition to the brain, the investigators aim to use functional magnetic resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy subjects and chronic neck pain patients. The information gained from this study will increase the investigators understanding of how chronic pain is encoded in the nervous system and assist in developing more effective treatment strategies.
Read the detailed description
The experimental design is an observational (non-interventional) cross-sectional clinical study. The principal goal of the proposed research is to utilize functional magnetic resonance imaging to further investigate and characterize pain-related neural activity at the level of the brain, brainstem, and spinal cord in healthy subjects and chronic neck pain patients. Healthy subjects and chronic neck pain patients will be recruited and participate in a single session of data collection. For both the healthy and chronic neck pain groups, painful thermal stimuli will be applied over the skin of the upper extremity while whole brain, brainstem, and cervical spinal cord functional images are acquired (on separate scans). For the chronic neck pain group, additional scans (brain, brainstem, and cervical spinal cord) will be acquired while the subjects rate their spontaneous chronic neck pain.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Functional Magnetic Resonance Imaging
- Keywords
- Brain, Brain Stem, Spinal Cord, Neurophysiology, Magnetic Resonance Imaging
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingOther
Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Functional magnetic resonance imaging of healthy subjects Receives: Other: Functional Magnetic Resonance Imaging | |
| Chronic neck pain patients | Functional magnetic resonance imaging of chronic neck pain patients Receives: Other: Functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging
Use functional magnetic resonance imaging to characterize brain, brainstem, and spinal cord pain processing in healthy subjects (thermal pain) and chronic neck pain patients (thermal pain and spontaneous clinical pain).
Measured: 1.5-2.25 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Todd Parrish, Northwestern University
- Investigators
- Todd Parrish, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356315
- Sponsor's protocol ID
- STU00067625
- Other IDs
- 5F32AT007800-03
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI
- ClinicalTrials.gov ID
- NCT02356315
- Acronym / sponsor ID
- STU00067625
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- Brain, Brain Stem, Spinal Cord, Neurophysiology, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2015 (estimated)
- 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.
New advances in medical imaging have allowed for the measurement of brain activity related to chronic pain. In addition to the brain, the investigators aim to use functional magnetic resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy subjects and chronic neck pain patients. The information gained from this study will increase the investigators understanding of how chronic pain is encoded in the nervous system and assist in developing more effective treatment strategies.
Detailed description
The experimental design is an observational (non-interventional) cross-sectional clinical study. The principal goal of the proposed research is to utilize functional magnetic resonance imaging to further investigate and characterize pain-related neural activity at the level of the brain, brainstem, and spinal cord in healthy subjects and chronic neck pain patients. Healthy subjects and chronic neck pain patients will be recruited and participate in a single session of data collection. For both the healthy and chronic neck pain groups, painful thermal stimuli will be applied over the skin of the upper extremity while whole brain, brainstem, and cervical spinal cord functional images are acquired (on separate scans). For the chronic neck pain group, additional scans (brain, brainstem, and cervical spinal cord) will be acquired while the subjects rate their spontaneous chronic neck pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Functional Magnetic Resonance ImagingFunctional magnetic resonance imaging of healthy subjects |
| Chronic neck pain patients | – | Other: Functional Magnetic Resonance ImagingFunctional magnetic resonance imaging of chronic neck pain patients |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects and chronic neck pain patients recruited from the community
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 |
|---|---|---|
| Functional Magnetic Resonance ImagingFunctional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity. | Other | Chronic neck pain patients, Healthy subjects |
Primary outcome
Functional magnetic resonance imaging
Time frame: 1.5-2.25 hours
Use functional magnetic resonance imaging to characterize brain, brainstem, and spinal cord pain processing in healthy subjects (thermal pain) and chronic neck pain patients (thermal pain and spontaneous clinical pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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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.
Todd Parrish, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Chronic Pain, run by Northwestern University at 1 site 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?
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: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional magnetic resonance imaging (time frame: 1.5-2.25 hours). 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 21 Dec 2015.