Clinical trial NCT02164630: Optimizing Resilience In Orofacial Pain and Nociception
Official title: Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorder
Keywords: Temporomandibular Joint Disorder
TMD
Hope
Resilience
Cognitive Behavior Therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Pain Society
First posted: 2014-06-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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:

1. Examine the degree to which state and trait levels of hope are predictive of clinical pain, disability, affective distress, and experimental pain.
2. Investigate the effects of a hope intervention, as compared to an education control group, on clinical and experimental pain in individuals with TMD.
3. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* currently pregnant and/or nursing
* use of narcotic analgesics (i.e., opioids) on a daily basis
* a primary pain condition other than TMD

Primary outcomes:
measure: Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
timeFrame: Baseline, Week 5
measure: Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
timeFrame: Baseline, Week 5
Secondary outcomes:
measure: Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5
timeFrame: Baseline, Week 5
measure: Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5
timeFrame: Baseline, Week 5
measure: Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5
timeFrame: Baseline, Week 5
measure: Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5
timeFrame: Baseline, Week 5
measure: Change from baseline in sensory pain stimuli at week 5
timeFrame: Baseline, Week 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Pain Research and Intervention Center of Excellence (PRICE)
state: Florida
Study officials:
affiliation: University of Florida
name: Emily J Bartley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: