Skills Training and Relief for Orofacial Pain

NCT07802067 | Not Yet Recruiting

• 1 other identifier: 119306
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immediate Intervention; Waitlist Control

Keywords

Orofacial Pain; Empowered Relief; Psychological Intervention

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  The number of patients who are consented into the study from the UK Orofacial Pain Clinic per month

  Baseline (week 0)

• Retention Rate

  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

  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

  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

  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 Outcomes (12)

• PTSD Symptoms

  Baseline (Week 0)

• Headache Impact

  Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)

• PTSD Symptoms (Past Two Weeks)

  Two Week Follow up (Week 2), One Month Follow up (Week 4)

• Pain Self Efficacy

  Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)

• Pain Catastrophizing

  Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants in this arm will be scheduled to partake in the next available Empowered Relief course

Behavioral: Empowered Relief

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

Interventions

Empowered Relief BEHAVIORAL

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.

Immediate Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40509, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen E Wakeman, M.S.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Ian Boggero, PhD

  University of Kentucky

  STUDY CHAIR

Central Study Contacts

Kathleen E Wakeman, M.S.

CONTACT

508-759-8037; kewa246@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 3, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)