Skills Training and Relief for Orofacial Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kentucky

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be in the state of Kentucky

Must be 18 years or older

Ability to read, write, and speak English

Experienced pain longer than 3 months

Disqualifiers

Suicidal ideation with intent in the last two weeks

Homicidal ideation with intent in the last 2 weeks

Mania symptoms in the past 6 months

Hypomania symptoms in the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Immediate InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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.
4

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.

Secondary outcomes

1

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)
2

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)
3

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)
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)

Other outcomes

Sponsors and contacts

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