Temporomandibular Joint Disorder Clinical Trial
— ORIONOfficial title:
Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Florida, Pain Research and Intervention Center of Excellence (PRICE) | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | American Pain Society |
United States,
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 |
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