N/A
N=21
TMD Online Program for Pain Management
TMD/Orofacial Pain
Bottom Line
View on ClinicalTrials.gov: NCT05862870 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Treatment Feasibility — 18 Participants — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- painTRAINER (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UConn Health
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Feasibility |
18 | .05 |
| PRIMARY The Treatment Credibility/Expectancy Questionnaire |
21 | — |
| SECONDARY Patient Pain: Change in Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) Score |
1.7 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT05862870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.