Temporomandibular Joint SyndromeNCT00067366
Brief Treatment for Temporomandibular Pain
A study testing Cognitive-Behavioral treatment and Attention and lifestyle counseling in people with Temporomandibular Joint Syndrome and Myofascial Pain Dysfunction Syndrome, run by UConn Health at 1 site in United States.
Trial summary
Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Syndrome, Myofascial Pain Dysfunction Syndrome, Orofacial Pain
- What is being tested?
- Cognitive-Behavioral treatment and Attention and lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2011
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaining of chronic TM-related pain for at least 3 months
- Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment
- Fluency in English
Who cannot join
- No previous surgery for treatment of TMD pain
- No history of rheumatoid disease
- No extensive anatomical destruction or deterioration of the TM joint
- Not diagnosed as having pain of neuropathic or odontogenic origin
- Not carrying a diagnosis of psychosis
- No current treatment for depression
- Not taking narcotic pain medication
- Not pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Brief Focused Treatment for TMD: Mechanisms of Action
Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.
Read the detailed description
TMD is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment. Men and women (N=106) with complaints of chronic facial pain for at least 3 months' duration will be recruited from the University Dental Clinics and from the community via advertisements and randomly assigned to either a Standard Conservative Treatment (STD) employing an intraoral splint plus anti-inflammatory agents, or to a Standard Treatment + Cognitive-Behavioral Treatment Program (STD+CBT), that will include standard treatment but also focus on changing self-efficacy and decreasing catastrophization. Both treatments will entail 6 clinic visits. Dispositional and situational variables derived from a comprehensive model of pain coping will be measured before and after treatment. The situational variables, including coping responses, mood states, situational appraisals and self-efficacy, will be measured in an experience sampling paradigm four times daily using a hand-held computer. This will be done to minimize retrospective biases that may have hampered earlier studies of treatment process. Dependent variables will be self-report measures of distress, pain, and interference with activities, as well as blood plasma levels of cortisol and selected cytokines, measured at the end of the 6-week treatment period, and at follow-up points thereafter up to a 12-month follow-up. It is expected that the STD+CBT treatment will result in measurable changes in constructs such as self-efficacy and catastrophization, and that these changes will be related to improved outcomes compared to the STD controls. It is also expected that outcome differences between groups will be associated with changes in inflammatory mediators (cytokine levels). Finally, it is suggested that changes in situational treatment process variables will be associated with changes in cytokine levels. The results may indicate the true active mechanisms of successful TMD treatment. If these mechanisms can be successfully identified it would have important implications for the development of more effective treatment programs.
- Being tested
- Cognitive-Behavioral treatment, Attention and lifestyle counseling
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Fibromyalgia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral treatmentBehavioural
Cognitive-Behavioral skills training for chronic pain
Attention and lifestyle counselingBehavioural
Attention and lifestyle counseling added to Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Coping Skills Training | Experimental | manualized coping skills training delivered along with conservative care Receives: Behavioral: Cognitive-Behavioral treatment |
| Standard Care | Active comparator | Attention and life counseling added to Standard conservative care Receives: Behavioral: Attention and lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Multidimensional pain ratings collected in person every 3 months
Measured: Every 3 months out to 12 months
Pain-related interference with functioning
Multidimensional function ratings collected in person every 3 months
Measured: every 3 months out to 12 months
Depressive symptoms
CES-D depressive symtpoms scale administered in perosn every 3 months.
Measured: Every 3 months out to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2003 (estimated)
- Study startOct 2003
- Primary completionOct 2008
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Litt, UConn Health
- Investigators
- Mark D Litt, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067366
- Sponsor's protocol ID
- NIDCR-14607
- Status last verified
- Jul 2017
- First submitted
- 15 Aug 2003
- Last updated
- 1 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Focused Treatment for TMD: Mechanisms of Action
- ClinicalTrials.gov ID
- NCT00067366
- Acronym / sponsor ID
- NIDCR-14607
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Aug 2003 (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.
Temporomandibular Disorder (TMD) is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment.
Detailed description
TMD is a widespread chronic pain condition. Successful psychosocial treatments for TMD have been developed, but the mechanisms by which these treatments achieve their effects are not well known. The goal of this project is to evaluate the possible mechanisms responsible for treatment gains in TMD treatment. Men and women (N=106) with complaints of chronic facial pain for at least 3 months' duration will be recruited from the University Dental Clinics and from the community via advertisements and randomly assigned to either a Standard Conservative Treatment (STD) employing an intraoral splint plus anti-inflammatory agents, or to a Standard Treatment + Cognitive-Behavioral Treatment Program (STD+CBT), that will include standard treatment but also focus on changing self-efficacy and decreasing catastrophization. Both treatments will entail 6 clinic visits. Dispositional and situational variables derived from a comprehensive model of pain coping will be measured before and after treatment. The situational variables, including coping responses, mood states, situational appraisals and self-efficacy, will be measured in an experience sampling paradigm four times daily using a hand-held computer. This will be done to minimize retrospective biases that may have hampered earlier studies of treatment process. Dependent variables will be self-report measures of distress, pain, and interference with activities, as well as blood plasma levels of cortisol and selected cytokines, measured at the end of the 6-week treatment period, and at follow-up points thereafter up to a 12-month follow-up. It is expected that the STD+CBT treatment will result in measurable changes in constructs such as self-efficacy and catastrophization, and that these changes will be related to improved outcomes compared to the STD controls. It is also expected that outcome differences between groups will be associated with changes in inflammatory mediators (cytokine levels). Finally, it is suggested that changes in situational treatment process variables will be associated with changes in cytokine levels. The results may indicate the true active mechanisms of successful TMD treatment. If these mechanisms can be successfully identified it would have important implications for the development of more effective treatment programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Skills Training | Experimental | Behavioral: Cognitive-Behavioral treatmentmanualized coping skills training delivered along with conservative care |
| Standard Care | Active comparator | Behavioral: Attention and lifestyle counselingAttention and life counseling added to Standard conservative care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complaining of chronic TM-related pain for at least 3 months
- Positive Axis I diagnosis on the Research Diagnostic Criteria (RDC) for temporomandibular disorders (positive on at least one Group), and may have no contraindications to TMD treatment
- Fluency in English
Key exclusion criteria (8 listed)
- No previous surgery for treatment of TMD pain
- No history of rheumatoid disease
- No extensive anatomical destruction or deterioration of the TM joint
- Not diagnosed as having pain of neuropathic or odontogenic origin
- Not carrying a diagnosis of psychosis
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 |
|---|---|---|
| Cognitive-Behavioral treatmentCognitive-Behavioral skills training for chronic pain | Behavioural | Coping Skills Training |
| Attention and lifestyle counselingAttention and lifestyle counseling added to Standard Care | Behavioural | Standard Care |
Primary outcome
Pain
Time frame: Every 3 months out to 12 months
Multidimensional pain ratings collected in person every 3 months
Pain-related interference with functioning
Time frame: every 3 months out to 12 months
Multidimensional function ratings collected in person every 3 months
Depressive symptoms
Time frame: Every 3 months out to 12 months
CES-D depressive symtpoms scale administered in perosn every 3 months.
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 1 Aug 2017.
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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.
Mark D Litt, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral treatment and Attention and lifestyle counseling in people with Temporomandibular Joint Syndrome and Myofascial Pain Dysfunction Syndrome, run by UConn Health 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 8 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 1 Aug 2017. 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?
Pain (time frame: Every 3 months out to 12 months). The study lists 3 primary outcomes in all. 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 1 Aug 2017.