Skills Training and Relief for Orofacial Pain: Feasibility and Acceptability of a Single Session Pain Management Course in a Tertiary Orofacial Pain Clinic
| Registry | NCT07802067, acronym STAR |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | University of Kentucky (Other) |
| Conditions | Chronic Orofacial Pain, Orofacial Pain |
| Interventions | Empowered Relief (Behavioral) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-09-03, last updated 2026-10-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Orofacial Pain All trials for Orofacial Pain All trials of Empowered Relief
Chronic orofacial pain conditions (COFP) are associated with substantial physical and psychological burden and are best treated with multidisciplinary approaches combining psychological interventions and comprehensive orofacial pain care. Yet, important barriers prevent access to psychological interventions for COFP (e.g., lack of providers, financial resources). This study will assess the feasibility and acceptability of adapting a single two-hour telehealth-delivered group course, Empowered Relief (ER), which was created for heterogenous chronic pain condition, into a multidisciplinary COFP clinic. ER addresses many existing barriers to assessing psychological interventions for COFP as it is deliverable via telehealth, in a group format, within a single session. This study hypothesizes that ER will demonstrate adequate feasibility and acceptability among patients with COFP. Participants will be recruited over a 6-month period from patients evaluated for an initial appointment at the University of Kentucky Orofacial Pain Clinic (UKOPC). A randomized waitlist control design will be used to inform a future efficacy trial. Specifically, new patients seeking an initial appointment at the UKOPC will be introduced to the study, and if they consent, they will be randomly assigned to participate in the next available ER course (i.e., immediate group) or the ER course offered the subsequent month (i.e., waitlist control group). All participants will provide feasibility and acceptability data after receiving the intervention. Those assigned to immediate group will provide biopsychosocial functioning and outcome data at one, two, and four weeks following the pain course. Those assigned to the immediate control group will provide data one, two, and four weeks before the intervention for a comparison group. Data from this study will inform design decisions for a future efficacy trial.
Chronic orofacial pain (COFP) is comprised of various disorders in the temporomandibular region causing pain that lasts more than three months and are associated with substantial physical and psychological burden. These disorders often co-occur with other conditions such as headache, general chronic pain, and psychiatric disorders. The etiology of COFP is complex, with environmental, psychosocial, emotional, and genetic factors contributing to the development, chronicity, and maintenance of these disorders. Regardless of etiology, COFPs are impactful, commonly resulting in interference with daily activities, reduced quality of life (QoL), and mental health difficulties. COFP disorders are therefore best treated with multidisciplinary approaches combining psychological interventions and comprehensive orofacial pain care.
Numerous psychological interventions for chronic pain are available, drawing from numerous theoretical orientations. Cognitive behavioral therapy (CBT) is a goal focused intervention designed to teach patients skills in restructuring cognitive distortions and thought patterns while promoting self-efficacy, which have shown to reduce pain intensity and psychological distress. Many relaxation techniques use a self-management approach by encouraging patients' role in managing their condition by learning skills to implement within their daily routine. Carlson (2008) categorizes multiple methods of relaxation techniques ranging from brief, easily taught skills to structured therapist-led interventions. He categorizes multiple methods of relaxation techniques ranging from brief, easily taught skills (brief relaxation techniques) to structured therapist-led interventions such as Physical Self-Regulation, where a therapist trains the patient through breathing exercises, clenching awareness, postural relaxation, and postural reeducation (progressive relaxation training).
Despite the multitude of empirically-supported psychological interventions available, they all share common obstacles; namely, that uptake of these interventions in COFP clinic is low due to lack of sufficient specialized orofacial pain treatment providers, financial resources, and mental health stigma, and patients not expecting to have clinical psychologists involved in their COFP management, which has historically been treated (with minimal success) by dental providers alone, among other obstacles. Additionally, while literature suggests the effectiveness of these interventions for COFP populations, patients are often met with access related issues. These treatments introduce barriers through financial costs associated with healthcare and travel, lack of geographic access, especially for patients in rural communities, and few professionally certified clinicians to provide services. Consequently, there is also a lack of multimodal tertiary clinics available that offer treatments combining dental, psychological, and behavioral healthcare, leading patients to travel far distances for interdisciplinary treatments that can last hours across multiple sessions. Geographic access also poses a significant issue because interdisciplinary COFP clinics are scarce, with many states not having any access to specialty care, despite their being empirical evidence for greater longitudinal outcomes in COFP patients.
Recent literature has identified Empowered Relief (ER), a virtual single-session, two-hour group-based intervention developed at Stanford University that overcomes many of the existing obstacles. ER introduces evidenced-based skills through a single session, two-hour course where patients develop tools that allow them to become self-sufficient in managing their chronic pain. The session can be held through a virtual format, providing accessible care and reducing patient travel or long stays. The training also provides space for multiple patients to receive care at one time as ER is hosted in a group format, allowing more patients to receive treatment over time.
The effectiveness of ER was first demonstrated through a pilot study that included participants with various chronic pain conditions which indicated significant reduction in distress and improved participants' ability to use self-regulation strategies for pain management 4 weeks post intervention. Additionally, a randomized control study found that one session of ER was just as effective as eight weeks of traditional CBT for reducing pain catastrophizing and pain intensity in individuals with chronic lower back pain. Currently, no literature to date has investigated the feasibility and acceptability of ER in patients with COFP, indicating a gap in literature. The present study aims to fill this gap to work towards the identification of a low-cost and low-burden intervention for this underserved population.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Empowered Relief | Participants in this arm will be scheduled to partake in the next available Empowered Relief course |
| Waitlist Control | No intervention | Participants in this arm will be scheduled to partake in the Empowered Relief course approximately 1 month after they consent for the study |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Must be in the state of Kentucky * Must be 18 years or older * Ability to read, write, and speak English * Experienced pain longer than 3 months * Treatment-seeking patient at University of Kentucky Orofacial Pain Clinic * Must have the appropriate technology to access telehealth (e.g., laptop, stable connection) Exclusion Criteria: * Suicidal ideation with intent in the last two weeks * Homicidal ideation with intent in the last 2 weeks * Mania symptoms in the past 6 months * Hypomania symptoms in the past 6 months * Psychosis symptoms in the past 6 months
| Facility | City | Country | Status |
|---|---|---|---|
| University of Kentucky | Lexington, Kentucky | United States |