Temporomandibular Joint DisorderORIONNCT02164630
Optimizing Resilience In Orofacial Pain and Nociception
A study testing Hope Therapy and Pain Education in people with Temporomandibular Joint Disorder, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a hope-based intervention on clinical and experimental pain in individuals with temporomandibular disorder (TMD). To examine the effectiveness of this intervention, a two-arm randomized trial will be conducted with 50 individuals, between the ages of 18 and 65… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorder
- What is being tested?
- Hope Therapy and Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2016
- 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
- participants between the ages of 18 and 65
- meets Research Diagnostic Criteria for TMD
- duration of pain is at least 3 months
- pain at least 15 days in the past month
- pain rated moderate to severe in intensity
Who cannot join
- uncontrolled hypertension
- current heart disease including heart failure
- kidney failure or currently undergoing dialysis
- current neurological conditions that could affect protocol safety or validity
- facial trauma or orofacial surgery within the last 6 months
- currently in orthodontic treatment
Show all 9Show fewer
- currently pregnant and/or nursing
- use of narcotic analgesics (i.e., opioids) on a daily basis
- a primary pain condition other than TMD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Pain Research and Intervention Center of Excellence (PRICE)
Gainesville, Florida, 32610
About this study
Official title: Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
The purpose of this study is to examine the effects of a hope-based intervention on clinical and experimental pain in individuals with temporomandibular disorder (TMD). To examine the effectiveness of this intervention, a two-arm randomized trial will be conducted with 50 individuals, between the ages of 18 and 65, who have TMD.
Read the detailed description
In recent years, there has been increasing interest in the contribution of positive psychological factors (e.g., optimism, pain acceptance, hope) to pain and pain-related coping. Although research supports the significance of these resilience factors in pain adaptation, psychological interventions based upon bolstering resilience have received far less attention. Emerging evidence supports the role of hope in psychosocial adjustment and enhancement of adaptive pain coping skills. Hope is considered to be a positive motivational state consisting of one's belief in their ability to generate routes to achieve goals (pathways) and initiation towards attaining these goals (agency). In the context of pain, increasing hope may promote augmentation of personal strengths to enhance development of meaningful goal pursuits and foster resilient outcomes. Enhancement of hopeful thinking and behavior may ultimately lead to the minimization of losses that are often associated with chronic pain. This experience may be also reflected physiologically, as increasing hope may confer biological benefits (e.g., decreased inflammation). Although hope-based interventions have been successfully applied in other clinical conditions (i.e., cancer), their utility in chronic pain disorders has not been examined.
To examine the effectiveness of this approach, a two-arm randomized trial will be conducted with individuals who have TMD. In Study Arm 1, participants will receive hope-based therapy. In Study Arm 2, participants will receive pain education. Participants will attend 5 sessions over a period of 5 weeks. Two of these sessions will involve quantitative sensory pain testing; three sessions will include delivery of the treatment intervention. Pain outcomes will be measured at pre- and post-treatment.
Aims:
- Examine the degree to which state and trait levels of hope are predictive of clinical pain, disability, affective distress, and experimental pain.
- Investigate the effects of a hope intervention, as compared to an education control group, on clinical and experimental pain in individuals with TMD.
- Identify psychosocial (e.g., hope, optimism, positive affect, catastrophizing), biological (e.g., inflammatory, endogenous opioid, neuroendocrine), and psychophysical factors associated with positive treatment response (i.e., reduction of clinical pain).
- Conditions
- Temporomandibular Joint Disorder
- Being tested
- Hope Therapy, Pain Education
- Keywords
- Temporomandibular Joint Disorder, TMD, Hope, Resilience, Cognitive Behavior Therapy
- 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.
Hope TherapyBehavioural
Hope therapy is designed to address key components of hope theory through augmentation of hopeful thinking and enhancement of goal-directed activities. Training focuses on effective goal setting, mobilization of internal resources to reach goals, identification of resilience factors to formulate hopeful thinking, and enhancing maintenance of future goal development.
Pain EducationOther
Pain Education is aimed to increase understanding of TMD symptomatology and etiology, as well as provide general education on pain, lifestyle management, and effective pain communication methods.
| Study group | Role | What they receive |
|---|---|---|
| Hope Therapy | Experimental | Patients assigned to this arm will receive Hope Therapy in three individual intervention sessions. Intervention will be administered by an experienced therapist.Training focuses on effective goal setting and augmenting hopeful thinking. Receives: Behavioral: Hope Therapy |
| Pain Education | Other | Patients assigned to this arm will receive Pain Education in three individual intervention sessions. Intervention will be administered by an experienced therapist. Training will focus on understanding TMD-related pain and learning pain management techniques. Receives: Other: Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
The Adult State Hope Scale is a 6-item inventory used to assess goal-directed thinking at a given moment in time.
Measured: Baseline, Week 5
Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
0-100 Numerical Rating Scale used to assess clinical pain intensity.
Measured: Baseline, Week 5
Secondary outcomes (5)
Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5
Measurement of interleukin 6 (IL-6), beta-endorphin, cortisol, and alpha-amylase.
Measured: Baseline, Week 5
Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5
The LOT-R is a 10-item measure assessing generalized positive outcome expectancies.
Measured: Baseline, Week 5
Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5
The PANAS is a 20-item scale that assesses positive affect (PA) and negative affect (NA).
Measured: Baseline, Week 5
Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5
The PCS is a 13-item measure used to assess patient report of catastrophic thinking about pain
Measured: Baseline, Week 5
Change from baseline in sensory pain stimuli at week 5
Measurement of heat pain threshold, heat pain tolerance, pressure pain threshold, cold pain threshold, and cold pain tolerance. Threshold = when stimulus (in seconds) is first rated as "painful"; Tolerance = when stimulus (in seconds) is no longer able to be tolerated.
Measured: Baseline, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Pain Society
- Responsible party
- Sponsor
- Investigators
- Emily J Bartley, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164630
- Sponsor's protocol ID
- IRB201400260
- Acronym
- ORION
- Status last verified
- Aug 2016
- First submitted
- 12 Jun 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT02164630
- Acronym / sponsor ID
- ORION / IRB201400260
- Conditions
- Temporomandibular Joint Disorder
- Keywords
- Temporomandibular Joint Disorder, TMD, Hope, Resilience, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Pain Society
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jun 2014 (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.
The purpose of this study is to examine the effects of a hope-based intervention on clinical and experimental pain in individuals with temporomandibular disorder (TMD). To examine the effectiveness of this intervention, a two-arm randomized trial will be conducted with 50 individuals, between the ages of 18 and 65, who have TMD.
Detailed description
In recent years, there has been increasing interest in the contribution of positive psychological factors (e.g., optimism, pain acceptance, hope) to pain and pain-related coping. Although research supports the significance of these resilience factors in pain adaptation, psychological interventions based upon bolstering resilience have received far less attention. Emerging evidence supports the role of hope in psychosocial adjustment and enhancement of adaptive pain coping skills. Hope is considered to be a positive motivational state consisting of one's belief in their ability to generate routes to achieve goals (pathways) and initiation towards attaining these goals (agency). In the context of pain, increasing hope may promote augmentation of personal strengths to enhance development of meaningful goal pursuits and foster resilient outcomes. Enhancement of hopeful thinking and behavior may ultimately lead to the minimization of losses that are often associated with chronic pain. This experience may be also reflected physiologically, as increasing hope may confer biological benefits (e.g., decreased inflammation). Although hope-based interventions have been successfully applied in other clinical conditions (i.e., cancer), their utility in chronic pain disorders has not been examined.
To examine the effectiveness of this approach, a two-arm randomized trial will be conducted with individuals who have TMD. In Study Arm 1, participants will receive hope-based therapy. In Study Arm 2, participants will receive pain education. Participants will attend 5 sessions over a period of 5 weeks. Two of these sessions will involve quantitative sensory pain testing; three sessions will include delivery of the treatment intervention. Pain outcomes will be measured at pre- and post-treatment.
Aims:
- Examine the degree to which state and trait levels of hope are predictive of clinical pain, disability, affective distress, and experimental pain.
- Investigate the effects of a hope intervention, as compared to an education control group, on clinical and experimental pain in individuals with TMD.
- Identify psychosocial (e.g., hope, optimism, positive affect, catastrophizing), biological (e.g., inflammatory, endogenous opioid, neuroendocrine), and psychophysical factors associated with positive treatment response (i.e., reduction of clinical pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hope Therapy | Experimental | Behavioral: Hope TherapyPatients assigned to this arm will receive Hope Therapy in three individual intervention sessions. Intervention will be administered by an experienced therapist.Training focuses on effective goal setting and augmenting hopeful thinking. |
| Pain Education | Other | Other: Pain EducationPatients assigned to this arm will receive Pain Education in three individual intervention sessions. Intervention will be administered by an experienced therapist. Training will focus on understanding TMD-related pain and learning pain management techniques. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- participants between the ages of 18 and 65
- meets Research Diagnostic Criteria for TMD
- duration of pain is at least 3 months
- pain at least 15 days in the past month
- pain rated moderate to severe in intensity
Key exclusion criteria (9 listed)
- uncontrolled hypertension
- current heart disease including heart failure
- kidney failure or currently undergoing dialysis
- current neurological conditions that could affect protocol safety or validity
- facial trauma or orofacial surgery within the last 6 months
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 |
|---|---|---|
| Hope TherapyHope therapy is designed to address key components of hope theory through augmentation of hopeful thinking and enhancement of goal-directed activities. Training focuses on effective goal setting, mobilization of internal resources to reach goals, identification of resilience factors to formulate hopeful thinking, and enhancing maintenance of future goal development. | Behavioural | Hope Therapy |
| Pain EducationPain Education is aimed to increase understanding of TMD symptomatology and etiology, as well as provide general education on pain, lifestyle management, and effective pain communication methods. | Other | Pain Education |
Primary outcome
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
Time frame: Baseline, Week 5
The Adult State Hope Scale is a 6-item inventory used to assess goal-directed thinking at a given moment in time.
Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
Time frame: Baseline, Week 5
0-100 Numerical Rating Scale used to assess clinical pain intensity.
5 secondary outcomes
Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5
Time frame: Baseline, Week 5
Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5
Time frame: Baseline, Week 5
Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5
Time frame: Baseline, Week 5
Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5
Time frame: Baseline, Week 5
Change from baseline in sensory pain stimuli at week 5
Time frame: Baseline, Week 5
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 Aug 2016.
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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.
Emily J Bartley, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Therapy and Pain Education in people with Temporomandibular Joint Disorder, run by University of Florida 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 5 inclusion and 9 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 4 Aug 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. 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?
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5 (time frame: Baseline, Week 5). The study lists 2 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 4 Aug 2016.