An interventional study of Empowered Relief in Chronic Orofacial Pain and Orofacial Pain, sponsored by University of Kentucky. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Kentucky · Not applicable, Interventional, and Treatment
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.
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 132 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →University of Kentucky is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this arm will be scheduled to partake in the next available Empowered Relief course
Behavioral: Empowered Relief
Participants in this arm will be scheduled to partake in the Empowered Relief course approximately 1 month after they consent for the study
Empowered Relief (ER) is a single-session, 2-hour pain management course designed with the purpose of assisting individuals with chronic pain to gain skills for self-pain management. ER is taught through a PowerPoint presentation which includes pain education, self-regulatory skills (i.e., relaxation, cognitive reframing, and self-soothing), and mindfulness skills, all grounded in pain-CBT theory (Darnall et al., 2021). The intervention will be delivered by a certified Empowered Relief instructor.
Recruitment Rate
The number of patients who are consented into the study from the UK Orofacial Pain Clinic per month
Time frame: Baseline (week 0)
Retention Rate
The number of patients who were consented into the study and completed the one month follow-up outcome survey
Time frame: Follow up outcome survey at one month (approximately)
Client Satisfaction
Client Satisfaction Questionnaire (CSQ) 8 items on a 4 point likert scale. Higher scores on items 1, 3, 6, 7, likert scale equate to greater satisfaction. Higher scores on items 2, 4, 5, and 8 likert scale equate to lower satisfaction.
Time frame: Immediate Intervention - approximately one week after consent and directly after pain management intervention attendance. Waitlist Control - approximately one month after consent and directly after pain management intervention attendance.
Empowered Relief Post Course Survey
Empowered Relief Post-Course Survey 5 items on a 6 point Likert scale. Higher scores equate to greater satisfaction with Empowered Relief course, content, and practice.
Time frame: Immediate Intervention - approximately one week after consent and directly after pain management intervention attendance. Waitlist Control - approximately one month after consent and directly after pain management intervention attendance.
Satisfaction with Class
Satisfaction with Class (Empowered Relief) is a 11 item survey. Items 1 - 5 are on a 0 to 10 numeric scale with higher scores equating to greater satisfaction. Items 6 - 10 are on a 7 point Likert scale with higher scores equating to greater satisfaction. Item 11 is a closed-ended single select question which includes three answer options.
Time frame: Immediate Intervention - approximately one week after consent and directly after pain management intervention attendance. Waitlist Control - approximately one month after consent and directly after pain management intervention attendance.
PTSD Symptoms
The PTSD Symptom Checklist (Past Month) (PCL-5) will assess if the participant has experienced a traumatic event as defined by the DSM-5-TR and if they have experienced PTSD symptoms in the past month related to the event. The PCL-5 is a 20 item questionnaire with each item rated on a 5-point likert scale ranging from 0 - 4. Higher scores equate to greater intensity and interference of PTSD symptoms.
Time frame: Baseline (Week 0)
Headache Impact
The Headache Impact Test (HIT-6) 6 item questionnaire evaluates pain intensity, life interference, and psychological distress due to headaches. Items are rated on a 5 point likert scale. Higher scores equate greater headache impact.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
PTSD Symptoms (Past Two Weeks)
The PTSD Short Form (PCL-5-SF) are administered to participants who indicate having experienced a trauma. The PCL-5-SF is a 4 item questionnaire on a 5 point likert scale. Higher scores equate to greater PTSD symptoms.
Time frame: Two Week Follow up (Week 2), One Month Follow up (Week 4)
Pain Self Efficacy
The Pain Self-Efficacy Questionnaire (PSEQ-2) includes two items with a 6 point likert scale. Lower scores equate to less pain self-efficacy.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Catastrophizing
The University of Washington Concerns About Pain Scale (UW-CAP-6) evaluates participants pain catastrophizing and negative thoughts in regard to their chronic pain. UW-CAP-6 short form includes 6 items rated on a 5 point likert scale with higher scores equating to greater levels of pain catastrophizing.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Acceptance of Chronic Pain
The Chronic Pain Acceptance Questionnaire (CPAQ-8) is an 8 item questionnaire that evaluates participants acceptance of their chronic pain condition. Items are rated on a 7 point likert scale with higher scores equating to greater pain acceptance.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Interference
The PROMIS Pain Interference Short Form (PROMIS 4a) evaluates how much pain interferes with their daily life. The PROMIS 4a includes 4 items rated on a 5 point likert scale with higher scores equating to pain having greater interference on their life.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Anxiety and Depression
The Patient Health Questionnaire (PHQ-4) is a brief questionnaire evaluating the participants anxiety and depression with 4 items rated on a 4 point likert scale with higher scores equating to greater levels of distress.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Fatigue
The PROMIS-FAT-4 is a brief questionnaire that evaluates participants level and impact of fatigue with 4 items on a 5 point likert scale with higher scores equating to greater severity of fatigue.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Satisfaction with Life
The Satisfaction with Life Scale (SWLS) evaluates participants judgement of satisfaction with the conditions of their life with 5 items rated on a 7 point likert scale with higher scores equating to greater satisfaction with their life's conditions.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Jaw Function
The Jaw Functional Limitation Scale (JFLS) short form evaluates participants jaw function limitations with 8 items on an 11 point numeric scale with higher scores equating to greater jaw function limitation.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Insomnia Severity
The Insomnia Severity Index (ISI-brief) evaluates the participants experience with sleep and the the severity and impact of insomnia if present. The brief ISI measure includes 7 items on a 5 point likert scale with higher scores equating to greater impact and severity of insomnia symptoms.
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Plan to share: No — Participant health data will be protected.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 53 non-industry interventional studies with no phase under Facial Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 12 months is below that.
Counting every sponsor, half of 57 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Kentucky