NCT02164630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

June 12, 2014

Last Update Submit

August 2, 2016

Conditions

Temporomandibular Joint Disorder

Keywords

Temporomandibular Joint DisorderTMDHopeResilienceCognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5

    Baseline, Week 5

  • Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5

    Baseline, Week 5

  • 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

  • Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5

    Baseline, Week 5

  • Change from baseline in sensory pain stimuli at week 5

    Baseline, Week 5

Study Arms (2)

Hope Therapy

EXPERIMENTAL

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.

Behavioral: Hope Therapy

Pain Education

OTHER

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.

Other: Pain Education

Interventions

Hope TherapyBEHAVIORAL

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.

Hope Therapy
Pain EducationOTHER

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.

Pain Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Emily J Bartley, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

US(1)