TMD Online Program for Pain Management

NCT ID: NCT05862870

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-08-31

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.

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.

Conditions

TMD/Orofacial Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

painTRAINER

Intervention Type: BEHAVIORAL

patient self-administered pain management web application

Interventions

painTRAINER

patient self-administered pain management web application

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Mark Litt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Litt, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Heatlh

Locations

UConn Health

Farmington, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3U01DE028520-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-052-1

Identifier Type: -

Identifier Source: org_study_id