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Optimizing Resilience In Orofacial Pain and Nociception (ORION)

Primary Purpose

Temporomandibular Joint Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hope Therapy
Pain Education
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorder focused on measuring Temporomandibular Joint Disorder, TMD, Hope, Resilience, Cognitive Behavior Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida, Pain Research and Intervention Center of Excellence (PRICE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hope Therapy

Pain Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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
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.

Full Information

First Posted
June 12, 2014
Last Updated
August 2, 2016
Sponsor
University of Florida
Collaborators
American Pain Society
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1. Study Identification

Unique Protocol Identification Number
NCT02164630
Brief Title
Optimizing Resilience In Orofacial Pain and Nociception
Acronym
ORION
Official Title
Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Pain Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorder
Keywords
Temporomandibular Joint Disorder, TMD, Hope, Resilience, Cognitive Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hope Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Pain Education
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hope Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
Description
The Adult State Hope Scale is a 6-item inventory used to assess goal-directed thinking at a given moment in time.
Time Frame
Baseline, Week 5
Title
Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
Description
0-100 Numerical Rating Scale used to assess clinical pain intensity.
Time Frame
Baseline, Week 5
Secondary Outcome Measure Information:
Title
Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5
Description
Measurement of interleukin 6 (IL-6), beta-endorphin, cortisol, and alpha-amylase.
Time Frame
Baseline, Week 5
Title
Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5
Description
The LOT-R is a 10-item measure assessing generalized positive outcome expectancies.
Time Frame
Baseline, Week 5
Title
Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5
Description
The PANAS is a 20-item scale that assesses positive affect (PA) and negative affect (NA).
Time Frame
Baseline, Week 5
Title
Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5
Description
The PCS is a 13-item measure used to assess patient report of catastrophic thinking about pain
Time Frame
Baseline, Week 5
Title
Change from baseline in sensory pain stimuli at week 5
Description
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.
Time Frame
Baseline, Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily J Bartley, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Pain Research and Intervention Center of Excellence (PRICE)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Optimizing Resilience In Orofacial Pain and Nociception

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