Optimizing Resilience In Orofacial Pain and Nociception

Temporomandibular Joint Disorder Clinical Trial

— ORION  

Official title:

Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164630
• Other study ID #: IRB201400260
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: August 2, 2016
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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, who have TMD.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
• Hope Therapy
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.

Other:
• Pain Education
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.

Locations

Country	Name	City	State
United States	University of Florida, Pain Research and Intervention Center of Excellence (PRICE)	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Pain Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 5	No
Primary	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.	Baseline, Week 5	No
Secondary	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.	Baseline, Week 5	No
Secondary	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.	Baseline, Week 5	No
Secondary	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).	Baseline, Week 5	No
Secondary	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	Baseline, Week 5	No
Secondary	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.	Baseline, Week 5	No