Temporomandibular Joint DisordersCVSNCT01502709
Neurostimulation in Temporomandibular Disorders (TMD) Patients
A study testing Caloric Vestibular Neurostimulation in people with Temporomandibular Joint Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized blinded placebo-controlled clinical trial in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either active treatment (caloric vestibular neurostimulation) or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Caloric Vestibular Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- English speaking
- Females with chronic TMD
Who cannot join
- History of any of the following: Terminal, progressive and /or unstable medical illness; Previous head or neck surgery for neoplasm; current chemotherapy or radiation therapy; facial trauma or orofacial surgery within the last 6 weeks; seizures, history of drug or alcohol abuse; Otologic disorders including chronic vertigo, chronic tinnitus, otitis external, otitis media, mastoiditis and tympanic membrane perforation; Stroke, transient ischemia attacks or Arnold- Chiari malformation; significant cardiac or respiratory disease; epilepsy or neurological disorders such as dementia, brain injury, and brain tumor
- Subjects who score ≥ 31 on the Becks depression inventory (performed at first appointment)
- History of or current destructive nerve therapies, defibrillator, pacemakers, deep brain stimulator, or Implantable nerve stimulators
- Utilization of other alternative or complementary therapies during the study period
- Participation in a clinical trial involving the use of a clinical devise in the last 30 days
- Women who are currently pregnant or nursing.
Show all 11Show fewer
- Patients who are left handed.
- Current orthodontic treatment.
- Use of an opiate in the 48 hour period preceding the baseline study visit
- The use of anti-histamines 6 hours before, during or immediately after the treatment period
- The use of anti-nausea or anti-vertigo drugs 6 hours before or during the treatment period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: Randomized Blinded Placebo-Controlled Clinical Trial of Caloric Vestibular Neurostimulation in Patients With Chronic TMD
The investigators propose to conduct a randomized blinded placebo-controlled clinical trial in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and symptoms of TMD, and any adverse events.
Read the detailed description
Temporomandibular disorders (TMD) are musculoskeletal pain conditions characterized by pain in the temporomandibular joint and/or the masticatory muscles. TMD are amongst the most common chronic musculoskeletal conditions affecting 6 to 12% of the general population yet there are no medicines approved specifically for its treatment. TMD cause substantial suffering and TMD pain is the most common symptom that compels patients to seek therapy. One study found average ratings of pain intensity due to TMD of 4.3 on a 10-point scale, similar to the averages reported for chest pain and back pain. Studies consistently find that TMD has a pronounced impact on quality of life. Thus, a new successful approach to TMD therapy would have a significant clinical and economic impact.
Caloric vestibular stimulation (CVS) is a routine diagnostic test for the assessment of vestibular function and Central nervous system pathology. It is usually conducted by instilling cold or warm water into the external ear canal and has been shown to activate anterior cingulate, temporoparietal and insular cortices. In addition to its use as a diagnostic test, CVS has also been shown to reduce pain in several chronic conditions including migraine, phantom limb pain, spinal cord injury, thalamic pain, and complex regional pain syndrome.
Central sensitization is a common feature of the pain conditions shown to be alleviated by CVS. It is a dysfunctional state of the central nervous system in which pain is no longer coupled to a noxious peripheral stimulus. In the presence of central sensitization the response to a noxious stimulus is exaggerated and prolonged (hyperalgesia) and may involve areas outside the site of injury (secondary hyperalgesia). Pain can also arise spontaneously and can be elicited by innocuous stimuli (allodynia). While the neural mechanisms underlying the development of TMD are poorly understood, there is accumulating evidence that central sensitization plays a critical role in TMD pathogenesis. It has been proposed that there is a cyclical process in which TMD pain results in central sensitization that in turn predisposes patients to more pain. Thus any treatment that reverses central sensitization should in turn result in a decrease in pain.
Caloric vestibular stimulation (CVS) is a safe and effective procedure used for the diagnosis of brainstem injury and for balance assessment. As noted already, there have been intriguing observations in the literature suggesting that caloric vestibular stimulation can lead to the abatement of pain. When a caloric stimulation (warm or cool relative to body temperature) is applied to the ear canal, conduction (primarily via dense bone) to the inner ear, and in particular the prominence of the lateral semicircular canal (SCC), sets up convection currents in the endolymph. The resultant deformation of the cupula (membrane spanning the ampula of the SCC) leads to a phasic change in the tonic firing rate of hair cells at the base of the cupula, thereby altering the firing rate of the afferents of the vestibular nerve (thus a device delivering CVS may be viewed as a class of neurostimulator). The afferents map to nuclei in the brainstem (as well as some phylogenetically ancient, direct connections, e.g. to the thalamus and hippocampus) and then to the fastigial nuclei in the cerebellum. It is hypothesized that the method of action of CVS on pain relates to alteration of the phasic firing rate in the vestibular nerve afferents, which in turn alters the activation of the receiving areas (brainstem and cerebellum).
The primary impediment to therapeutic applications of CVS has been the lack of a clinical device that provides controlled, prolonged, and repeatable caloric stimulation. The use of "ice water" irrigation using syringes or even the water/air irrigators used in balance studies are not practical for treatment regimens that extend up to 10 minutes. Further, the applicants believe that a controlled, time-varying thermal waveform is essential to avoid the effects of adaptation of the cupula, which then attenuates control of the phasic firing rate of the hair cells.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Caloric Vestibular Neurostimulation, placebo
- Keywords
- Single blind, Randomized, Controlled clinical trial
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Vestibular NeurostimulationDevice
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
placeboDevice
Matching placebo device
| Study group | Role | What they receive |
|---|---|---|
| Caloric Vestibular Neurostimulation | Experimental | Subjects received caloric vestibular neurostimulation Receives: Device: Caloric Vestibular Neurostimulation |
| Placebo Arm | Placebo comparator | Subjects received placebo Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment
The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.
Measured: Daily Self-reports at Baseline and on Days 1 through 7
Secondary outcomes (2)
Mean Percentage of Time Spent in Pain From Days 1-7
The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.
Measured: Days 1-7
Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam
RDC for Temporomandibular disorders (TMD) is a reliable \& valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: recruiting difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Khan, BDS, PhD, University of North Carolina, Chapel Hill
- Investigators
- Asma Khan, BDS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502709
- Sponsor's protocol ID
- CVS-TMD-001
- Acronym
- CVS
- Status last verified
- Apr 2016
- First submitted
- 6 Dec 2011
- Last updated
- 26 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blinded Placebo-Controlled Clinical Trial of Caloric Vestibular Neurostimulation in Patients With Chronic TMD
- ClinicalTrials.gov ID
- NCT01502709
- Acronym / sponsor ID
- CVS / CVS-TMD-001
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Single blind, Randomized, Controlled clinical trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Posted 26 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct a randomized blinded placebo-controlled clinical trial in patients with chronic TMD (N=20). Patients will be randomly assigned to receive either active treatment (caloric vestibular neurostimulation) or placebo. Data will be collected prior to and after treatment on thermal and mechanical pain thresholds, clinical signs and symptoms of TMD, and any adverse events.
Detailed description
Temporomandibular disorders (TMD) are musculoskeletal pain conditions characterized by pain in the temporomandibular joint and/or the masticatory muscles. TMD are amongst the most common chronic musculoskeletal conditions affecting 6 to 12% of the general population yet there are no medicines approved specifically for its treatment. TMD cause substantial suffering and TMD pain is the most common symptom that compels patients to seek therapy. One study found average ratings of pain intensity due to TMD of 4.3 on a 10-point scale, similar to the averages reported for chest pain and back pain. Studies consistently find that TMD has a pronounced impact on quality of life. Thus, a new successful approach to TMD therapy would have a significant clinical and economic impact.
Caloric vestibular stimulation (CVS) is a routine diagnostic test for the assessment of vestibular function and Central nervous system pathology. It is usually conducted by instilling cold or warm water into the external ear canal and has been shown to activate anterior cingulate, temporoparietal and insular cortices. In addition to its use as a diagnostic test, CVS has also been shown to reduce pain in several chronic conditions including migraine, phantom limb pain, spinal cord injury, thalamic pain, and complex regional pain syndrome.
Central sensitization is a common feature of the pain conditions shown to be alleviated by CVS. It is a dysfunctional state of the central nervous system in which pain is no longer coupled to a noxious peripheral stimulus. In the presence of central sensitization the response to a noxious stimulus is exaggerated and prolonged (hyperalgesia) and may involve areas outside the site of injury (secondary hyperalgesia). Pain can also arise spontaneously and can be elicited by innocuous stimuli (allodynia). While the neural mechanisms underlying the development of TMD are poorly understood, there is accumulating evidence that central sensitization plays a critical role in TMD pathogenesis. It has been proposed that there is a cyclical process in which TMD pain results in central sensitization that in turn predisposes patients to more pain. Thus any treatment that reverses central sensitization should in turn result in a decrease in pain.
Caloric vestibular stimulation (CVS) is a safe and effective procedure used for the diagnosis of brainstem injury and for balance assessment. As noted already, there have been intriguing observations in the literature suggesting that caloric vestibular stimulation can lead to the abatement of pain. When a caloric stimulation (warm or cool relative to body temperature) is applied to the ear canal, conduction (primarily via dense bone) to the inner ear, and in particular the prominence of the lateral semicircular canal (SCC), sets up convection currents in the endolymph. The resultant deformation of the cupula (membrane spanning the ampula of the SCC) leads to a phasic change in the tonic firing rate of hair cells at the base of the cupula, thereby altering the firing rate of the afferents of the vestibular nerve (thus a device delivering CVS may be viewed as a class of neurostimulator). The afferents map to nuclei in the brainstem (as well as some phylogenetically ancient, direct connections, e.g. to the thalamus and hippocampus) and then to the fastigial nuclei in the cerebellum. It is hypothesized that the method of action of CVS on pain relates to alteration of the phasic firing rate in the vestibular nerve afferents, which in turn alters the activation of the receiving areas (brainstem and cerebellum).
The primary impediment to therapeutic applications of CVS has been the lack of a clinical device that provides controlled, prolonged, and repeatable caloric stimulation. The use of "ice water" irrigation using syringes or even the water/air irrigators used in balance studies are not practical for treatment regimens that extend up to 10 minutes. Further, the applicants believe that a controlled, time-varying thermal waveform is essential to avoid the effects of adaptation of the cupula, which then attenuates control of the phasic firing rate of the hair cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caloric Vestibular Neurostimulation | Experimental | Device: Caloric Vestibular NeurostimulationSubjects received caloric vestibular neurostimulation |
| Placebo Arm | Placebo comparator | Device: placeboSubjects received placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years
- English speaking
- Females with chronic TMD
Key exclusion criteria (11 listed)
- History of any of the following: Terminal, progressive and /or unstable medical illness; Previous head or neck surgery for neoplasm; current chemotherapy or radiation therapy; facial trauma or orofacial surgery within the last 6 weeks; seizures, history of drug or alcohol abuse; Otologic disorders including chronic vertigo, chronic tinnitus, otitis external, otitis media, mastoiditis and tympanic membrane perforation; Stroke, transient ischemia attacks or Arnold- Chiari malformation; significant cardiac or respiratory disease; epilepsy or neurological disorders such as dementia, brain injury, and brain tumor
- Subjects who score ≥ 31 on the Becks depression inventory (performed at first appointment)
- History of or current destructive nerve therapies, defibrillator, pacemakers, deep brain stimulator, or Implantable nerve stimulators
- Utilization of other alternative or complementary therapies during the study period
- Participation in a clinical trial involving the use of a clinical devise in the last 30 days
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 |
|---|---|---|
| Caloric Vestibular Neurostimulation1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear | Device | Caloric Vestibular Neurostimulation |
| placeboMatching placebo device | Device | Placebo Arm |
Primary outcome
Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment
Time frame: Daily Self-reports at Baseline and on Days 1 through 7
The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.
2 secondary outcomes
Mean Percentage of Time Spent in Pain From Days 1-7
Time frame: Days 1-7
Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Asma Khan, BDS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Vestibular Neurostimulation in people with Temporomandibular Joint Disorders, run by University of North Carolina, Chapel Hill 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment (time frame: Daily Self-reports at Baseline and on Days 1 through 7). 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 26 Apr 2016.