Clinical Research Directory

Skills Training and Relief for Orofacial Pain

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.

Orofacial Pain Self-management: Personality Moderation Effect

The objective of this clinical trial is to study the effect of self-management on pain perception in patients with chronic orofacial pain and temporomandibular disorders (TMD) comparing it with the conventional treatment proposed by the TMD clinical practice guidelines. It also evaluates its effect on function and various psychosocial variables. As a secondary objective, this work proposes to study the variability between patients, in terms of personality factors, as moderators of the effect of treatment on pain perception. Including in the proposed statistical models certain covariates such as perception and/or coping with stress, anxiety and other psychosocial variables. This is a randomized clinical trial with two intervention groups and three measurement times (T0; pre-intervention, T1; post-5 weeks and T2; post-6 months). The experimental group will be applied a protocol based on self-management, which includes: therapeutic education, cognitive-behavioral tools, therapeutic exercise of the temporomandibular region, mind-body strategies and modifications of aspects related to lifestyle. The control group will carry out an intervention program based on the Clinical Practice Guidelines for the Management of Temporomandibular Joint Disorders. Therefore, using a set of tools based on therapeutic education, cognitive-behavioral tools for bruxism and other parafunctional habits, temporomandibular region exercises and manual therapy.