TMD Online Program for Pain Management

Mobile Application Treatment for TMD: Feasibility Trial

This is a proposal for an administrative supplement to the parent study, "Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism" (U01 DE028520). The parent study is currently engaged in exploring the extent to which the training of coping skills per se is an important mechanism of psychosocial treatment. The current project seeks to lay the groundwork for expanding the range of treatment mechanisms examined to include therapeutic relationship factors (therapist support, empathy, acknowledgment). The present supplemental study will provide instruction for individual patient pain management via an online application, with no therapist or counselor assistance. The aim is to determine the extent to which treatment-related outcomes (including adherence and pain) may be influenced by therapist support factors.

Study Overview

• Status: Completed
• Conditions: TMD/Orofacial Pain
• Intervention / Treatment: Behavioral: painTRAINER

Detailed Description

Psychosocial treatments have been effective for temporomandibular disorders (TMD), but the mechanisms of action for these treatments are unclear. Most studies of psychosocial treatment, including the parent U01, have focused on relatively specific psychosocial mechanisms, including coping skills acquisition, pain management self-efficacy, decrease in catastrophizing, increased mindfulness, acceptance, and readiness to change behavior to ameliorate pain. The 2 therapist-delivered treatments in the parent study are packaged CBT or Individualized Assessment and Treatment (IATP). Left untested in this study are common therapeutic factors that often emerge as influential in pain outcome research. These common, non-specific therapeutic factors include (especially): the therapeutic alliance; interpretation and understanding; emotional expression; reinforcement; information; and reassurance and support. Because both conditions of the parent U01 involve similar levels of therapist involvement, therapist support and other treatment-non-specific variables cannot be tested clearly. One way to assess these factors is to introduce a pain treatment that explicitly does not contain these factors; i.e., a treatment that does not employ therapists or require supervision by health care professionals. There are currently no studies published in which therapist-led treatments have been compared to a mobile application-based treatment.

The Investigators therefore propose to pilot test a mobile application treatment condition (painTrainer©) added as an additional treatment condition to the parent study, and provided to 20 patients in the coming year. This condition will deliver the content of the CBT condition of the parent study, but will do so with no therapist contact. If this mobile application is found credible and acceptable it may be used in additional comparisons with treatments conducted by therapists. Thus at some point it will be possible to parse the effects of cognitive-behavioral treatment content per se and therapist support factors.

An additional benefit of testing such a mobile application is that it might in the future provide a means to expand the reach of pain management professionals to remote and underserved populations.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age at least 18 years
• Complaint of either bilateral or unilateral pain, scoring > 3 on a 11-point pain scale (scored from 0 to 10), in the area of the temporomandibular joint
• Pain has persisted for a period of at least 3 months by patient self-report. Pain may be constant or intermittent.

Exclusion Criteria:

• Contraindications to TMD treatment (as determined by the consulting oral surgeon)
• Inadequate fluency in English
• History of prior surgery for TMD
• Receiving concurrent treatment for orofacial pain (including orthodontic or physical therapy)
• Have a condition that requires the use of an oral appliance (e.g., sleep apnea)
• Diagnosed as having pain of neuropathic or odontogenic origin
• History of rheumatoid disease or autoimmune disease (e.g., rheumatoid arthritis; lupus) currently being treated with anti-inflammatory drugs
• History of kidney disease or current kidney issues
• Extensive anatomical destruction or deterioration of the TM joint
• Current treatment of chronic pain issue with anti-inflammatories (e.g., Indomethacin; methotrexate; dexamethasone) or opioid analgesics
• Carrying a diagnosis of psychosis (as per self-report on Quick Screen)
• Pregnant or anticipating pregnancy (due to prescription of NSAIDs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: painTRAINER pain management web application; This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions.	Behavioral: painTRAINER; patient self-administered pain management web application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Feasibility	Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program	8 months
Treatment Acceptability/Adherence Scale	Scores on Treatment Acceptability Scale.This is an 8-item scale assessing the extent to which a treatment was manageable or doable, without causing undue distress.Scores on the scale could range from 8 to 36, with higher scores indicating that the treatment was more acceptable.	3 months
The Treatment Credibility/Expectancy Questionnaire	The Treatment Credibility/Expectancy Questionnaire is composed of 4 questions that assess treatment credibility, or the extent to which a treatment seems logical and able to address patient complaints. The credibility scores may range from 4 to 36, with higher scores indicating greater endorsement of credibility.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain: Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score	Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score: GCPS-CPI is made up of 3 questions asking the patient to rate their pain Now, at its worst, and on average over the past 30 days. Scores on the index may range from 0 to 30, with higher scores indicative of greater characteristic pain.	3 months

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Facial Pain
• Other Study ID Numbers: 23-052-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary data will be made available to interested investigators by the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No