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临床试验/NCT07802067
NCT07802067尚未招募不适用

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

University of Kentucky1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Retention Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Immediate Intervention

Experimental

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

干预措施: Empowered Relief (Behavioral)

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

结局指标

主要结局

Retention Rate

时间窗: 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

Recruitment Rate

时间窗: Baseline (week 0)

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

Client Satisfaction

时间窗: 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.

Empowered Relief Post Course Survey

时间窗: 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.

Satisfaction with Class

时间窗: 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.

次要结局

  • 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))
  • Acceptance of Chronic Pain(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4))
  • Pain Interference(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))
  • Anxiety and Depression(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))
  • Fatigue(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))
  • Satisfaction with Life(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))
  • Jaw Function(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))
  • Insomnia Severity(Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ian Boggero, PhD

Associate Professor

University of Kentucky

研究点 (1)

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