ToothacheNCT02630771
Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
An observational study of Toothache and Temporomandibular Joint Disorders, run by University of Minnesota at 1 site in United States.
Trial summary
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Toothache, Temporomandibular Joint Disorders
- What is being tested?
- Pressure pain threshold
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2019
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females with age range 18-65 years
Who may be able to join
- Age- and handedness-matched painfree controls using frequency matching to maintain similar group averages:
- No self-report of persistent pain conditions for the last 6 months;
- No diagnosis of PDAP or TMD;
- PDAP only:
- Fulfilling diagnostic criteria per Nixdorf et al., 20122
- Characteristic dentoalveolar PDAP pain cannot be increased by pressure provocation from jaw muscle trigger points (referred pain)
- PDAP with TMD:
- Fulfilling diagnostic criteria for PDAP2 and chronic TMD myalgia per Schiffman et al. 20143
Who cannot join
- Self-report:
- Chronic widespread pain
- Current use of opioids or other pain medications (e.g., ibuprofen/acetaminophen) that cannot be stopped <3 days prior to testing
- Conditions/diseases associated with altered pain perception: neurological (e.g., multiple sclerosis, trigeminal neuralgia) psychiatric disorders, diabetes, neoplasm and cardiovascular disorders
- Injury to hands
- Substance abuse
- MRI contraindications including pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
About this study
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls.
Read the detailed description
Chronic orofacial pain disorders may present localized in the mouth such as with persistent dentoalveolar pain disorder (PDAP) or widespread in the head/face/jaw such as with temporomandibular disorders (TMD). PDAP pain manifests in a tooth that usually underwent root canal treatment or in the site formally occupied by such tooth, while TMD pain is usually reported over the preauricular area, jaws and temples. These commonly comorbid disorders have a significant impact on the individual and society. Their mechanisms are poorly understood with evidence suggesting deficient pain modulation and abnormal brain features. PDAP and TMD patients, when compared to controls, have abnormal sensory/pain processing as well as brain structural and functional differences.
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in PDAP patients with and without TMD. All measures from patients will be compared to painfree controls. This knowledge will support better understanding of mechanisms involved in PDAP and will support development of mechanistic-based clinical treatments for the patients the investigators serve. Findings from these investigations will likely contribute to our understanding of other chronic pain conditions.
- Conditions
- Toothache, Temporomandibular Joint Disorders
- Being tested
- Pressure pain threshold
- Medical subject headings
- Toothache, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure pain thresholdProcedure or surgery
Also called PPT
Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
| Study group | Role | What they receive |
|---|---|---|
| PDAP only | Persistent dentoalveolar pain disorder patients who do not fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation. Receives: Procedure: Pressure pain threshold | |
| PDAP + TMD | Persistent dentoalveolar pain disorder patients who also fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation. Receives: Procedure: Pressure pain threshold | |
| Painfree controls | Painfree subjects. Pressure pain threshold before/during conditioned pain modulation. Receives: Procedure: Pressure pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold change before and during conditioned pain modulation
Pressure pain thresholds will be determined over the skin overlaying the masseter muscles bilaterally and over the right thenar eminence using a pressure algometer before and during the application of a concurrent noxious heat stimulus to the left forearm.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothacheStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estephan J Moana-Filho, DDS, MS, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630771
- Sponsor's protocol ID
- 1511M80706
- Status last verified
- Apr 2019
- First submitted
- 2 Dec 2015
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain
- ClinicalTrials.gov ID
- NCT02630771
- Acronym / sponsor ID
- 1511M80706
- Conditions
- Toothache, Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 15 Dec 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.
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls.
Detailed description
Chronic orofacial pain disorders may present localized in the mouth such as with persistent dentoalveolar pain disorder (PDAP) or widespread in the head/face/jaw such as with temporomandibular disorders (TMD). PDAP pain manifests in a tooth that usually underwent root canal treatment or in the site formally occupied by such tooth, while TMD pain is usually reported over the preauricular area, jaws and temples. These commonly comorbid disorders have a significant impact on the individual and society. Their mechanisms are poorly understood with evidence suggesting deficient pain modulation and abnormal brain features. PDAP and TMD patients, when compared to controls, have abnormal sensory/pain processing as well as brain structural and functional differences.
This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in PDAP patients with and without TMD. All measures from patients will be compared to painfree controls. This knowledge will support better understanding of mechanisms involved in PDAP and will support development of mechanistic-based clinical treatments for the patients the investigators serve. Findings from these investigations will likely contribute to our understanding of other chronic pain conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDAP only | – | Procedure: Pressure pain thresholdPersistent dentoalveolar pain disorder patients who do not fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation. |
| PDAP + TMD | – | Procedure: Pressure pain thresholdPersistent dentoalveolar pain disorder patients who also fit criteria for TMD. Pressure pain threshold before/during conditioned pain modulation. |
| Painfree controls | – | Procedure: Pressure pain thresholdPainfree subjects. Pressure pain threshold before/during conditioned pain modulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females with age range 18-65 years
Key inclusion criteria (8 listed)
- Age- and handedness-matched painfree controls using frequency matching to maintain similar group averages:
- PDAP only:
- PDAP with TMD:
Key exclusion criteria (7 listed)
- Chronic widespread pain
- Current use of opioids or other pain medications (e.g., ibuprofen/acetaminophen) that cannot be stopped <3 days prior to testing
- Conditions/diseases associated with altered pain perception: neurological (e.g., multiple sclerosis, trigeminal neuralgia) psychiatric disorders, diabetes, neoplasm and cardiovascular disorders
- Injury to hands
- Substance abuse
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 |
|---|---|---|
| Pressure pain thresholdAlso: PPTPressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation | Procedure or surgery | PDAP + TMD, PDAP only, Painfree controls |
Primary outcome
Pressure pain threshold change before and during conditioned pain modulation
Time frame: Baseline
Pressure pain thresholds will be determined over the skin overlaying the masseter muscles bilaterally and over the right thenar eminence using a pressure algometer before and during the application of a concurrent noxious heat stimulus to the left forearm.
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 2 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Estephan J Moana-Filho, DDS, MS, PhD principal investigator
University of Minnesota
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 Toothache and Temporomandibular Joint Disorders, run by University of Minnesota 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?
The sponsor lists 8 inclusion and 7 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: finished, as of the sponsor's last update on 2 May 2019. 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?
Pressure pain threshold change before and during conditioned pain modulation (time frame: Baseline). 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 2 May 2019.