HealthyPhase 2NCT00078364
Pain Pathways in the Brain
A Phase 2 study testing MRI in people with Healthy and Tooth Extraction, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will evaluate brain pathways involved in feeling pain and pain relief following administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure brain activity at sites that become more active following oral surgery and then to see if the activity changes after pain medication is… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy, Tooth Extraction
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2005
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
ELIGIBILITY CRITERIA:
Subjects will be a convenience sample selected from the pool of 500 - 700 new patients screened annually for acute pain studies. Inclusion and Exclusion criteria will be applied to result in a homogeneous population of subjects with respect to the surgical difficulty of the tooth being extracted, a single lower right third molar.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Imaging Neural Mechanisms Underlying Pain Modulation
This study will evaluate brain pathways involved in feeling pain and pain relief following administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure brain activity at sites that become more active following oral surgery and then to see if the activity changes after pain medication is administered. MRI combines a powerful magnet with an advanced computer system and radio waves to produce detailed pictures of organs and tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom system at all times during the procedure.
Healthy dental patients recruited through the NIH Clinical Research Volunteer Program may enroll in this study. Participants will undergo the following tests and procedures in two clinic visits:
Read more
Visit 1 - Sensitivity Testing
Participants are tested for sensitivity to warm and hot temperatures. A probe is applied to the skin (usually the forearm) and heated to temperatures ranging from room temperature to that of a hot cup of coffee. Participants rate the temperature using a scale ranging from "no pain" to the "worst pain imaginable" and rate the unpleasantness of the heat using a similar scale. The probe is applied up to 30 times, using random heat intensities. Participants are also asked compare the heat intensity to varying levels of sounds and to rate the magnitude of different sensations they have experienced in the past, such as the brightness of the sun and the loudness of a jet plane. A blood sample of about 2 ounces is also collected at this visit for DNA analysis to look for genes related to pain.
Visit 2 - Oral Surgery
Under local anesthetic, participants undergo extraction of their lower right wisdom tooth. After surgery, the patient is moved to the MRI scanner for brain imaging over 1-2 hours while the local anesthetic wears off. Patients may request a postoperative pain drug (Toradol) during the procedure, if needed. When the scan is complete, patients are dismissed from the clinic with additional pain medication (flurbiprofen) to use at home as directed.
Read the detailed description
Functional neuroimaging provides a powerful tool for understanding how the brain may be involved in the perception of pain. It has made it possible to identify areas of the brain that are involved in the perception of experimental pain but very few studies have evaluated the sites in the brain that are activated during clinical pain and the effects of analgesic drugs. The proposed study will use the surgical removal of an impacted third molar as a model of acute clinical pain to identify sites that are activated following the offset of local anesthesia and to examine the effects of the NSAID analgesic ketorolac on attenuating sites that are activated as pain is relieved. Scans will be performed under non-pain baseline conditions, and again immediately following surgery as the local anesthetic wears off, clinical pain occurs, and following administration of the NSAID ketorolac. Differences among subjects in the amount of pain reported and brain activation will be compared to subjects' prior ratings of experimental pain and the presence of any genetic polymorphisms that are related to pain perception, inflammation, known pain pathways, or psychological factors related to pain. The findings from this research may help to reveal how pain is appreciated in the central nervous system, pharmacologically modified by NSAID analgesics and differs among individuals due to genetic factors.
- Conditions
- Healthy, Tooth Extraction
- Being tested
- MRI
- Keywords
- MRI, NSAID Analgesia, Pain Mechanisms, SNP's, Acute Pain, Wisdom Teeth, Third Molar Extraction, Third Molar Impaction
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2004 (estimated)
- Study startFeb 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078364
- Sponsor's protocol ID
- 040125
- Other IDs
- 04-D-0125
- Status last verified
- Aug 2005
- First submitted
- 23 Feb 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bingel U, Quante M, Knab R, Bromm B, Weiller C, Buchel C. Subcortical structures involved in pain processing: evidence from single-trial fMRI. Pain. 2002 Sep;99(1-2):313-21. doi: 10.1016/s0304-3959(02)00157-4.
PubMed 12237210Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.
PubMed 11166937Chen AC. New perspectives in EEG/MEG brain mapping and PET/fMRI neuroimaging of human pain. Int J Psychophysiol. 2001 Oct;42(2):147-59. doi: 10.1016/s0167-8760(01)00163-5.
PubMed 11587773
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Neural Mechanisms Underlying Pain Modulation
- ClinicalTrials.gov ID
- NCT00078364
- Acronym / sponsor ID
- 040125
- Conditions
- Healthy, Tooth Extraction
- Keywords
- MRI, NSAID Analgesia, Pain Mechanisms, SNP's, Acute Pain, Wisdom Teeth, Third Molar Extraction, Third Molar Impaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Feb 2004
- Study completion
- Aug 2005
- First posted
- 24 Feb 2004 (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.
This study will evaluate brain pathways involved in feeling pain and pain relief following administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure brain activity at sites that become more active following oral surgery and then to see if the activity changes after pain medication is administered. MRI combines a powerful magnet with an advanced computer system and radio waves to produce detailed pictures of organs and tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom system at all times during the procedure.
Healthy dental patients recruited through the NIH Clinical Research Volunteer Program may enroll in this study. Participants will undergo the following tests and procedures in two clinic visits:
Visit 1 - Sensitivity Testing
Participants are tested for sensitivity to warm and hot temperatures. A probe is applied to the skin (usually the forearm) and heated to temperatures ranging from room temperature to that of a hot cup of coffee. Participants rate the temperature using a scale ranging from "no pain" to the "worst pain imaginable" and rate the unpleasantness of the heat using a similar scale. The probe is applied up to 30 times, using random heat intensities. Participants are also asked compare the heat intensity to varying levels of sounds and to rate the magnitude of different sensations they have experienced in the past, such as the brightness of the sun and the loudness of a jet plane. A blood sample of about 2 ounces is also collected at this visit for DNA analysis to look for genes related to pain.
Visit 2 - Oral Surgery
Under local anesthetic, participants undergo extraction of their lower right wisdom tooth. After surgery, the patient is moved to the MRI scanner for brain imaging over 1-2 hours while the local anesthetic wears off. Patients may request a postoperative pain drug (Toradol) during the procedure, if needed. When the scan is complete, patients are dismissed from the clinic with additional pain medication (flurbiprofen) to use at home as directed.
Detailed description
Functional neuroimaging provides a powerful tool for understanding how the brain may be involved in the perception of pain. It has made it possible to identify areas of the brain that are involved in the perception of experimental pain but very few studies have evaluated the sites in the brain that are activated during clinical pain and the effects of analgesic drugs. The proposed study will use the surgical removal of an impacted third molar as a model of acute clinical pain to identify sites that are activated following the offset of local anesthesia and to examine the effects of the NSAID analgesic ketorolac on attenuating sites that are activated as pain is relieved. Scans will be performed under non-pain baseline conditions, and again immediately following surgery as the local anesthetic wears off, clinical pain occurs, and following administration of the NSAID ketorolac. Differences among subjects in the amount of pain reported and brain activation will be compared to subjects' prior ratings of experimental pain and the presence of any genetic polymorphisms that are related to pain perception, inflammation, known pain pathways, or psychological factors related to pain. The findings from this research may help to reveal how pain is appreciated in the central nervous system, pharmacologically modified by NSAID analgesics and differs among individuals due to genetic factors.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| MRI | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 12237210Bingel U, Quante M, Knab R, Bromm B, Weiller C, Buchel C. Subcortical structures involved in pain processing: evidence from single-trial fMRI. Pain. 2002 Sep;99(1-2):313-21. doi: 10.1016/s0304-3959(02)00157-4.
- Background: PubMed 11166937Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.
- Background: PubMed 11587773Chen AC. New perspectives in EEG/MEG brain mapping and PET/fMRI neuroimaging of human pain. Int J Psychophysiol. 2001 Oct;42(2):147-59. doi: 10.1016/s0167-8760(01)00163-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRI in people with Healthy and Tooth Extraction, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078364, which also lists 3 linked publications.
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 4 Mar 2008.