Empowered Relief for Facial Pain

(STAR Trial)

KE
Overseen ByKathleen E Wakeman, M.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kentucky
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

IB

Ian Boggero, PhD

Principal Investigator

University of Kentucky

KE

Kathleen E Wakeman, M.S.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults with chronic facial pain who are new patients at the University of Kentucky Orofacial Pain Clinic and are seeking their first appointment. Participants must be able to join a telehealth group session.

Inclusion Criteria

Ability to read, write, and speak English
I have had pain for more than 3 months.
I am 18 years old or older.
See 2 more

Exclusion Criteria

Participants reporting current or recent suicidal or homicidal ideation or intent in the last 2 weeks
I have had symptoms of mania, hypomania, or psychosis in the past 6 months.

What Are the Treatments Tested in This Trial?

Interventions

  • Empowered Relief

Trial Overview

The study tests a single, two-hour online group class called Empowered Relief, designed to teach coping skills for chronic facial pain. Patients are randomly assigned to take the course right away or after about a month (waitlist control).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Immediate InterventionExperimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials
198
Recruited
224,000+