Skills Training and Relief for Orofacial Pain (STAR)

August 30, 2026 updated by: Ian Boggero, PhD, University of Kentucky

SKILLS TRAINING AND RELIEF FOR OROFACIAL PAIN: FEASIBILITY AND ACCEPTABILITY OF A SINGLE SESSION PAIN MANAGEMENT COURSE IN A TERTIARY OROFACIAL PAIN CLINIC

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (e.g, anxiety and depression; Hernández-Nuño de la Rosa et al., 2023). The etiology of COFP is complex, with environmental, psychosocial, emotional, and genetic factors contributing to the development, chronicity, and maintenance of these disorders (Hernández-Nuño de la Rosa et al., 2023). Regardless of etiology, COFPs are impactful, commonly resulting in interference with daily activities, reduced quality of life (QoL), and mental health difficulties (Miller et al., 2026). 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 (Miller et al., 2026; Nagi et al., 2025; Tan et al., 2017; Carlson, 2008). 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 (Aggarwal et al., 2019; Nicholas & Blyth, 2016). 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) (Carlson, 2008).

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 (Melanie et al., 2026: Ziadni et al., 2021). 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 (Lagisetty et al., 2021). 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 (Miller et al., 2026; Esposito et al., 2026).

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 (Ziadni et al., 2021). 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 (Ziadni et al., 2021). 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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kathleen E Wakeman, M.S.
  • Phone Number: 508-759-8037
  • Email: kewa246@uky.edu

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • University of Kentucky
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be 18 years or older; have the ability to read, write, and speak English; have experienced pain longer than 3 months; be a treatment-seeking patient at the University of Kentucky Orofacial Pain Clinic (UKOPC), and have the technological ability to participate in telehealth treatment in Kentucky (e.g., technology, connection, earbuds or headphones, private space in Kentucky).

Exclusion Criteria:

  • Because the UKOPC is a training clinic, participants will be excluded if they report current or recent suicidal or homicidal ideation or intent in the last 2 weeks and/or symptoms of mania, hypomania, or psychosis in the past 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention
Participants in this arm will be scheduled to partake in the next available Empowered Relief course
Behavioral: Empowered Relief
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.
No Intervention: Waitlist Control
Participants in this arm will be scheduled to partake in the Empowered Relief course approximately 1 month after they consent for the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Baseline (week 0)
The number of patients who are consented into the study from the UK Orofacial Pain Clinic per month
Baseline (week 0)
Retention Rate
Time Frame: Follow up outcome survey at one month (approximately)
The number of patients who were consented into the study and completed the one month follow-up outcome survey
Follow up outcome survey at one month (approximately)
Client 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.
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.
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
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 5 items on a 6 point Likert scale. Higher scores equate to greater satisfaction with Empowered Relief course, content, and practice.
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
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 (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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptoms
Time Frame: Baseline (Week 0)
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.
Baseline (Week 0)
Headache Impact
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
PTSD Symptoms (Past Two Weeks)
Time Frame: Two Week Follow up (Week 2), One Month Follow up (Week 4)
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.
Two Week Follow up (Week 2), One Month Follow up (Week 4)
Pain Self Efficacy
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
The Pain Self-Efficacy Questionnaire (PSEQ-2) includes two items with a 6 point likert scale. Lower scores equate to less pain self-efficacy.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Catastrophizing
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Acceptance of Chronic Pain
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Interference
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Anxiety and Depression
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Fatigue
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Satisfaction with Life
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Jaw Function
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Insomnia Severity
Time Frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
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.
Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Investigators

  • Principal Investigator: Kathleen E Wakeman, M.S., University of Kentucky
  • Study Chair: Ian Boggero, PhD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 30, 2026

First Submitted That Met QC Criteria

August 30, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 119306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant health data will be protected.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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