TMD Online Program for Pain Management

NCT05862870 | Completed Results

• 2 other identifiers: 23-052-13U01DE028520-03S1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMD/Orofacial Pain

Outcome Measures

Primary Outcomes (2)

• Treatment Feasibility

  Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program. This number of patients recruited over this time period would indicate that the program is attractive to the target patient population. If this number finish the program, it would indicate that the program was a feasible means of intervention.

  8 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 Outcomes (1)

• Patient Pain: Change in Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) Score

  baseline to 3 months after treatment

Study Arms (1)

painTRAINER pain management web application

EXPERIMENTAL

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

Interventions

painTRAINER BEHAVIORAL

patient self-administered pain management web application

painTRAINER pain management web application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• UConn Health: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

Results Point of Contact

• Title: Mark D. Litt, PhD
• Organization: UConn Health

Litt@uchc.edu

860-679-4680

Study Officials

• Mark Litt, PhD

  UConn Heatlh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Feasibility study

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: December 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)