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Skills Training and Relief for Orofacial Pain (STAR)

2026년 10월 1일 업데이트: Ian Boggero, PhD, University of Kentucky

Skills Training and Relief for Orofacial Pain: Feasibility and Acceptability of a Single Session Pain Management Course in a Tertiary Orofacial Pain Clinic

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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. The etiology of COFP is complex, with environmental, psychosocial, emotional, and genetic factors contributing to the development, chronicity, and maintenance of these disorders. Regardless of etiology, COFPs are impactful, commonly resulting in interference with daily activities, reduced quality of life (QoL), and mental health difficulties. 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. 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. 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).

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. 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. 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.

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. 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. 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.

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Kathleen E Wakeman, M.S.
  • 전화번호: 508-759-8037
  • 이메일: kewa246@uky.edu

연구 장소

    • Kentucky
      • Lexington, Kentucky, 미국, 40509
        • University of Kentucky
        • 연락하다:
        • 연락하다:
          • Kathleen E Wakeman, M.S.
          • 전화번호: 5027598037
          • 이메일: kewa246@uky.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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
  • Treatment-seeking patient at University of Kentucky Orofacial Pain Clinic
  • Must have the appropriate technology to access telehealth (e.g., laptop, stable connection)

Exclusion Criteria:

  • 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
  • Psychosis symptoms in the past 6 months

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Immediate Intervention

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

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.

간섭 없음: Waitlist Control

Participants in this arm will be scheduled to partake in the Empowered Relief course approximately 1 month after they consent for the study

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment Rate
기간: Baseline (week 0)

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

Baseline (week 0)
Retention Rate
기간: 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

Follow up outcome survey at one month (approximately)
Client Satisfaction
기간: 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.

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
기간: 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.

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
기간: 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.

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.

2차 결과 측정

결과 측정
측정값 설명
기간
PTSD Symptoms
기간: Baseline (Week 0)

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.

Baseline (Week 0)
Headache Impact
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)

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.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
PTSD Symptoms (Past Two Weeks)
기간: Two Week Follow up (Week 2), One Month Follow up (Week 4)

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.

Two Week Follow up (Week 2), One Month Follow up (Week 4)
Pain Self Efficacy
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)

The Pain Self-Efficacy Questionnaire (PSEQ-2) includes two items with a 6 point likert scale. Lower scores equate to less pain self-efficacy.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Catastrophizing
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)

The University of Washington Concerns About Pain Scale (UW-CAP-6) evaluates participants pain catastrophizing and negative thoughts in regard to their chronic pain. UW-CAP-6 short form includes 6 items rated on a 5 point likert scale with higher scores equating to greater levels of pain catastrophizing.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Acceptance of Chronic Pain
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)

The Chronic Pain Acceptance Questionnaire (CPAQ-8) is an 8 item questionnaire that evaluates participants acceptance of their chronic pain condition. Items are rated on a 7 point likert scale with higher scores equating to greater pain acceptance.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Interference
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The PROMIS Pain Interference Short Form (PROMIS 4a) evaluates how much pain interferes with their daily life. The PROMIS 4a includes 4 items rated on a 5 point likert scale with higher scores equating to pain having greater interference on their life.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Anxiety and Depression
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The Patient Health Questionnaire (PHQ-4) is a brief questionnaire evaluating the participants anxiety and depression with 4 items rated on a 4 point likert scale with higher scores equating to greater levels of distress.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Fatigue
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The PROMIS-FAT-4 is a brief questionnaire that evaluates participants level and impact of fatigue with 4 items on a 5 point likert scale with higher scores equating to greater severity of fatigue.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Satisfaction with Life
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The Satisfaction with Life Scale (SWLS) evaluates participants judgement of satisfaction with the conditions of their life with 5 items rated on a 7 point likert scale with higher scores equating to greater satisfaction with their life's conditions.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Jaw Function
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The Jaw Functional Limitation Scale (JFLS) short form evaluates participants jaw function limitations with 8 items on an 11 point numeric scale with higher scores equating to greater jaw function limitation.

Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Insomnia Severity
기간: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)

The Insomnia Severity Index (ISI-brief) evaluates the participants experience with sleep and the the severity and impact of insomnia if present. The brief ISI measure includes 7 items on a 5 point likert scale with higher scores equating to greater impact and severity of insomnia symptoms.

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Kathleen E Wakeman, M.S., University of Kentucky
  • 연구 의자: Ian Boggero, PhD, University of Kentucky

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2027년 10월 1일

연구 완료 (추정된)

2028년 10월 1일

연구 등록 날짜

최초 제출

2026년 8월 30일

QC 기준을 충족하는 최초 제출

2026년 8월 30일

처음 게시됨 (실제)

2026년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 1일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Participant health data will be protected.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다