Optimizing Resilience In Orofacial Pain and Nociception

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorder
• Interventions: Behavioral: Hope Therapy; Other: Pain Education

• Registration Number: NCT02164630
• Lead Sponsor: University of Florida

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Study Start: 2014-09
• Primary Completion: 2015-12
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hope Therapy	Hope Therapy	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.
Pain Education	Pain Education	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5	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	Baseline, Week 5	0-100 Numerical Rating Scale used to assess clinical pain intensity.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5	Baseline, Week 5	Measurement of interleukin 6 (IL-6), beta-endorphin, cortisol, and alpha-amylase.
Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5	Baseline, Week 5	The LOT-R is a 10-item measure assessing generalized positive outcome expectancies.
Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5	Baseline, Week 5	The PANAS is a 20-item scale that assesses positive affect (PA) and negative affect (NA).
Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5	Baseline, Week 5	The PCS is a 13-item measure used to assess patient report of catastrophic thinking about pain
Change from baseline in sensory pain stimuli at week 5	Baseline, 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.

Trial Locations

Locations (1)

University of Florida, Pain Research and Intervention Center of Excellence (PRICE); 🇺🇸 Gainesville, Florida, United States