Chronic Orofacial PainSTARNCT07802067
Skills Training and Relief for Orofacial Pain
A study testing Empowered Relief in people with Chronic Orofacial Pain and Orofacial Pain, run by University of Kentucky at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Orofacial Pain, Orofacial Pain
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40509
Kathleen E Wakeman, M.S., 5027598037, kewa246@uky.edu
Ian Boggero, PhD, 859-562-3291, ian.boggero@uky.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Orofacial Pain, Orofacial Pain
- Being tested
- Empowered Relief
- Keywords
- Orofacial Pain, Empowered Relief, Psychological Intervention
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Participants in this arm will be scheduled to partake in the next available Empowered Relief course Receives: Behavioral: Empowered Relief |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The number of patients who are consented into the study from the UK Orofacial Pain Clinic per month
Measured: Baseline (week 0)
Retention Rate
The number of patients who were consented into the study and completed the one month follow-up outcome survey
Measured: Follow up outcome survey at one month (approximately)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 (12)
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.
Measured: Baseline (Week 0)
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
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.
Measured: Two Week Follow up (Week 2), One Month Follow up (Week 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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Catastrophizing
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Acceptance of Chronic Pain
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Interference
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Anxiety and Depression
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Fatigue
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Satisfaction with Life
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Jaw Function
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Insomnia Severity
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.
Measured: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Chronic Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Boggero, PhD, University of Kentucky
- Investigators
- Kathleen E Wakeman, M.S., Principal investigator, University of KentuckyIan Boggero, PhD, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802067
- Sponsor's protocol ID
- 119306
- Acronym
- STAR
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant health data will be protected.
Publications
Priyank H, Shankar Prasad R, Shivakumar S, Sayed Abdul N, Pathak A, Cervino G, Cicciu M, Minervini G. Management protocols of chronic Orofacial Pain: A Systematic Review. Saudi Dent J. 2023 Jul;35(5):395-402. doi: 10.1016/j.sdentj.2023.04.003. Epub 2023 May 13.
PubMed 37520608Lagisetty P, Slat S, Thomas J, Macleod C, Golmirzaie G, Bohnert AS. Access to Multimodal Pain Management for Patients with Chronic Pain: an Audit Study. J Gen Intern Med. 2021 Mar;36(3):818-820. doi: 10.1007/s11606-020-05866-3. Epub 2020 May 6. No abstract available.
PubMed 32378013Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014.
PubMed 24851056Davin SA, Abshire L, Thompson N, Savage J, Amps J, Pelle D, Steinmetz M. Acceptability of a brief behavioral pain treatment to enhance recovery after surgery. N Am Spine Soc J. 2026 Mar 27;26:100880. doi: 10.1016/j.xnsj.2026.100880. eCollection 2026 Jun.
PubMed 42063569Litt MD, Tennen H. What are the most effective coping strategies for managing chronic pain? Pain Manag. 2015;5(6):403-6. doi: 10.2217/pmt.15.45. Epub 2015 Sep 24. No abstract available.
PubMed 26399377Avinash B, Shivamallu AB, Ashwini TS, Sowmya HK, Ali I, Kudagi VS. Interprofessional Management of Orofacial Pain: Wearing Many Hats! J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S65-S67. doi: 10.4103/jpbs.JPBS_556_21. Epub 2022 Jul 13.
PubMed 36110700Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
PubMed 34022930Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011 Feb;31(3):357-67. doi: 10.1177/0333102410379890. Epub 2010 Sep 6.
PubMed 20819842Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
Tan, Gabriel & Glaros, Alan & Sherman, Richard & Wong, Chin. (2017). Integrative Approaches to Orofacial Pain: Role of Biofeedback and Hypnosis. 10.1007/978-3-319-51508-3_27.
Schrepf A, Maixner W, Fillingim R, Veasley C, Ohrbach R, Smith S, Williams DA. The Chronic Overlapping Pain Condition Screener. J Pain. 2024 Jan;25(1):265-272. doi: 10.1016/j.jpain.2023.08.009. Epub 2023 Aug 24.
PubMed 37633574Stone S, Wainwright E, Guest A, Ghiglieri C, Zeyen A, Gooberman-Hill R. Social influences in the experience of transition to or from long-term (chronic) pain: A systematic review of qualitative research studies. PLoS One. 2025 Jul 10;20(7):e0327984. doi: 10.1371/journal.pone.0327984. eCollection 2025.
PubMed 40638632Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Sangalli L, Fernandez-Vial D, Moreno-Hay I, Boggero I. Telehealth Increases Access to Brief Behavioral Interventions in an Orofacial Pain Clinic During the COVID-19 Pandemic: A Retrospective Study. Pain Med. 2022 Apr 8;23(4):799-806. doi: 10.1093/pm/pnab295.
PubMed 34623433Perez L, Palenski P, Monson EA, Contreras L, Dorsonne B, Hailu AY, Gedeon K, Boyd H, Ziadni M, Herrick A, Friedman A, Xu J, Hong J, Tian L, Darnall BD. Online 1-session Empowered Relief in Marfan syndrome and related diseases: a single-arm feasibility and pilot efficacy study. Sci Rep. 2026 Jan 6;16(1):499. doi: 10.1038/s41598-025-29943-x.
PubMed 41495090
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills Training and Relief for Orofacial Pain: Feasibility and Acceptability of a Single Session Pain Management Course in a Tertiary Orofacial Pain Clinic
- ClinicalTrials.gov ID
- NCT07802067
- Acronym / sponsor ID
- STAR / 119306
- Conditions
- Chronic Orofacial Pain, Orofacial Pain
- Keywords
- Orofacial Pain, Empowered Relief, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Empowered ReliefParticipants in this arm will be scheduled to partake in the next available Empowered Relief course |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefEmpowered 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. | Behavioural | Immediate Intervention |
Primary outcome
Recruitment Rate
Time frame: Baseline (week 0)
The number of patients who are consented into the study from the UK Orofacial Pain Clinic per month
Retention Rate
Time frame: 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
Client 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.
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
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.
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
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.
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.
12 secondary outcomes
PTSD Symptoms
Time frame: Baseline (Week 0)
Headache Impact
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow up (Week 4)
PTSD Symptoms (Past Two Weeks)
Time frame: Two Week Follow up (Week 2), One Month Follow up (Week 4)
Pain Self Efficacy
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Catastrophizing
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Acceptance of Chronic Pain
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow Up (Week 4)
Pain Interference
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Anxiety and Depression
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Fatigue
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Satisfaction with Life
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Jaw Function
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Insomnia Severity
Time frame: Baseline (Week 0), Two Week Follow Up (Week 2), One Month Follow-Up (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 37520608Priyank H, Shankar Prasad R, Shivakumar S, Sayed Abdul N, Pathak A, Cervino G, Cicciu M, Minervini G. Management protocols of chronic Orofacial Pain: A Systematic Review. Saudi Dent J. 2023 Jul;35(5):395-402. doi: 10.1016/j.sdentj.2023.04.003. Epub 2023 May 13.
- Background: PubMed 32378013Lagisetty P, Slat S, Thomas J, Macleod C, Golmirzaie G, Bohnert AS. Access to Multimodal Pain Management for Patients with Chronic Pain: an Audit Study. J Gen Intern Med. 2021 Mar;36(3):818-820. doi: 10.1007/s11606-020-05866-3. Epub 2020 May 6. No abstract available.
- Background: PubMed 24851056Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014.
- Background: PubMed 42063569Davin SA, Abshire L, Thompson N, Savage J, Amps J, Pelle D, Steinmetz M. Acceptability of a brief behavioral pain treatment to enhance recovery after surgery. N Am Spine Soc J. 2026 Mar 27;26:100880. doi: 10.1016/j.xnsj.2026.100880. eCollection 2026 Jun.
- Background: PubMed 26399377Litt MD, Tennen H. What are the most effective coping strategies for managing chronic pain? Pain Manag. 2015;5(6):403-6. doi: 10.2217/pmt.15.45. Epub 2015 Sep 24. No abstract available.
- Background: PubMed 36110700Avinash B, Shivamallu AB, Ashwini TS, Sowmya HK, Ali I, Kudagi VS. Interprofessional Management of Orofacial Pain: Wearing Many Hats! J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S65-S67. doi: 10.4103/jpbs.JPBS_556_21. Epub 2022 Jul 13.
- Background: PubMed 34022930Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
- Background: PubMed 20819842Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011 Feb;31(3):357-67. doi: 10.1177/0333102410379890. Epub 2010 Sep 6.
- BackgroundWeathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
- BackgroundTan, Gabriel & Glaros, Alan & Sherman, Richard & Wong, Chin. (2017). Integrative Approaches to Orofacial Pain: Role of Biofeedback and Hypnosis. 10.1007/978-3-319-51508-3_27.
- Background: PubMed 37633574Schrepf A, Maixner W, Fillingim R, Veasley C, Ohrbach R, Smith S, Williams DA. The Chronic Overlapping Pain Condition Screener. J Pain. 2024 Jan;25(1):265-272. doi: 10.1016/j.jpain.2023.08.009. Epub 2023 Aug 24.
- Background: PubMed 40638632Stone S, Wainwright E, Guest A, Ghiglieri C, Zeyen A, Gooberman-Hill R. Social influences in the experience of transition to or from long-term (chronic) pain: A systematic review of qualitative research studies. PLoS One. 2025 Jul 10;20(7):e0327984. doi: 10.1371/journal.pone.0327984. eCollection 2025.
- Individual participant dataSharing planned: No. Participant health data will be protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen E Wakeman, M.S. principal investigator
University of Kentucky
Ian Boggero, PhD study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief in people with Chronic Orofacial Pain and Orofacial Pain, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen E Wakeman, M.S. (508-759-8037, kewa246@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline (week 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07802067, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.