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?

This trial explores a new telehealth program called Empowered Relief, designed to assist individuals with chronic facial pain. The goal is to determine if a quick, two-hour online group session can effectively support those facing this type of pain and its associated challenges. Participants will either take the course immediately or wait about a month, enabling researchers to compare outcomes. Individuals who have experienced facial pain for more than three months and seek treatment at the University of Kentucky Orofacial Pain Clinic may be suitable candidates, particularly if they can access telehealth services. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance pain management strategies.

What prior data suggests that this telehealth-delivered group course is safe for patients with chronic orofacial pain?

Research has shown that Empowered Relief, a pain management class, is generally safe for participants. Studies have found it helps reduce pain, stress, anxiety, depression, and sleep problems, indicating it is well-tolerated by those who try it. Several trials demonstrated that Empowered Relief was as effective as Cognitive Behavioral Therapy (CBT) in managing pain without causing serious side effects. Current evidence also supports that this approach is practical and acceptable for people with chronic pain, offering them valuable skills without significant risks.12345

Why are researchers excited about this trial?

"Empowered Relief is unique because it offers a non-pharmacological approach to managing facial pain, contrasting with the standard medications like anticonvulsants and antidepressants typically used for this condition. This technique emphasizes cognitive-behavioral strategies, which aim to empower individuals by teaching them skills to manage pain effectively and reduce its impact on daily life. Researchers are excited about this method because it potentially offers a sustainable, side-effect-free alternative that could enhance patients' quality of life without relying on medications."

What evidence suggests that Empowered Relief is effective for chronic orofacial pain?

Research has shown that the Empowered Relief (ER) course may help manage long-term pain. Studies on similar pain treatments suggest that mental strategies can significantly improve pain management and enhance quality of life. Although specific data on ER for long-term face and jaw pain is limited, the course employs proven methods effective for other chronic pain types. Its design ensures easy access and use, potentially benefiting those who typically lack access to such help. Overall, early results suggest that ER could be a valuable tool for managing chronic orofacial pain. Participants in this trial will either receive the immediate intervention or join a waitlist control, participating in the Empowered Relief course approximately one month after consenting to the study.678910

Who Is on the Research Team?

KE

Kathleen E Wakeman, M.S.

Principal Investigator

University of Kentucky

IB

Ian Boggero, PhD

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single two-hour telehealth-delivered group course, Empowered Relief (ER), designed to manage chronic orofacial pain

2 hours
1 session (virtual)

Follow-up

Participants are monitored for biopsychosocial functioning and outcome data at one, two, and four weeks following the pain course

4 weeks
3 follow-up assessments (virtual)

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+

Citations

Facial

They are normally performed in beauty salons but are also a common spa treatment. They are used for general skin health as well as for specific skin conditions.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/8649870/

Development of a sensitive clinical facial grading system

The proposed system reports results in a more continuous manner with a wider response range than the House-Brackmann grades.

SB22-113 Artificial Intelligence Facial Recognition

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Facial Plastic Surgery Clinics of North America | Journal

Facial Plastic Surgery Clinics of North America updates you on the latest trends in patient management; keeps you up to date on the newest advances; ...

6.

contextualscience.org

contextualscience.org/node/50211

Empowered Relief® pain management class

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Stanford Pain Relief Innovations Lab

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Whole Person Pain – Empowered Relief

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Empowered Relief Intervention for People with Chronic Pain

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Empowered Relief (@EmpoweredRelief) ...

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