K23- Physical Self Regulation vs Placebo

Official title

Initial Evidence for a Brief Psychological Telehealth Intervention for Patients With Chronic Masticatory Muscle Pain

Overview

This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.

Detailed description

Chronic masticatory muscle pain disorders (MMPD) consist of several conditions (e.g., myofascial pain, local myalgia) characterized by pain in the muscles of the temporomandibular area lasting longer than three months. MMPD affects 5-12% of adults, is the most common cause of chronic non-odontogenic facial pain, and the second most common musculoskeletal pain condition after chronic low back pain. MMPD is associated with pain-related interference with daily activities, diminished quality of life (QoL) and costs of \> $4 billion/year in the US, representing a serious public health issue. Chronic MMPD is most effectively managed with multidisciplinary treatment. One brief psychological intervention that has been particularly promising for improving orofacial pain outcomes and QoL in MMPD is physical self-regulation (PSR). Relative to standard dental care (SDC) alone, those who received SDC+PSR experienced reduced pain intensity up to 6.5 months later (Cohen's D = 0.67). These data suggest that PSR may be a promising intervention for improving pain outcomes in MMPD. Despite the promise of PSR, one of its major shortcomings is that treatment utilization is low, with less than 50% of eligible patients beginning PSR when offered in person. Offering PSR via telehealth may be a solution. Telehealth interventions improve access to care and are preferred by patients over in-person interventions. Preliminary data of treatment utilization for PSR-TH are promising, with over 80% of eligible patients beginning the intervention when offered via telehealth. However, it is not known if PSR-TH is efficacious above and beyond nonspecific treatment effects (e.g., people having more contact with a therapist, people inadvertently modifying their behavior to please their therapist, natural regression to the mean of pain symptoms, etc.). The efficacy of PSR-TH to treat MMPD needs to be formally tested; however, additional data regarding feasibility and moderating/mediating factors of PSRTH are needed to support such a trial. First, PSR-TH and a control intervention need to be formally piloted in patients with MMPD to 1) determine how willing patients are to participate in research (i.e., recruitment), 2) determine the completion rates for both interventions (i.e., retention), 3) quantify how well interventionists are able to deliver the interventions in a standardized way (i.e., fidelity), and 4) establish patients' perceived acceptability, credibility, and burden of both interventions. Second, a body of work has examined biopsychosocial moderators and mediators of responses to psychological interventions (e.g., cognitive behavioral therapy, \[CBT\]) in MMPD, but never of PSR-TH specifically. Identifying relevant moderators and mediators in this project will allow for more thorough assessment of those specific relationships in a future Phase II trial, advancing understanding of how PSR-TH works, and for whom. To accomplish these aims, treatment-seeking patients with chronic MMPD will be randomly assigned to two 50-min telehealth sessions of PSR or a control intervention (N=52/group) and will provide biopsychosocial moderator, mediator, and outcome data at baseline, after each intervention sessions, two weeks following the intervention, and three months following the intervention. The investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). The investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.

Interventions

• Behavioral Physical Self Regulation Telehealth
  2 sessions of an intervention delivered via telehealth. Session 1 includes awareness and strategies for monitoring habits and 4 exercises to practice 5 times per day. Session 2 will be 2 weeks later and is a review of session 1 and an introduction to diaphragmatic breathing. Breathing is practiced for 15 minutes twice per day.
• Behavioral Psycho-education Telehealth
  2 sessions of an intervention delivered via telehealth. Session 1 includes discussing trigeminal nerve function, jaw and muscle anatomy, posture, pain referral patterns, and stress biology. Participants rate pain and jaw fatigue 5 times per day. Session 2 will be 2 weeks later and consists of checking on the homework and information from session 1,followed by a discussion of autonomic nervous system activity, and a discussion of sleep quality and sleep hygiene. Participants will be instructed to

Primary outcome measures

• Change in pain intensity [Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)]
• Change in pain interference [Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)]
• Change in quality of life [Time frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)]
• Recruitment rate [Time frame: Baseline (week 0)]
• Retention rate [Time frame: Follow up Visit at Month 3 (week 15)]
• Interventionist Fidelity Session 1 [Time frame: Study Visit 1 (week 1)]
• Interventionist Fidelity Session 2 [Time frame: Study Visit 2 (week 3)]
• Treatment Acceptability [Time frame: Study Visits 1 and 2 (up to 2 weeks)]
• Treatment Credibility [Time frame: Study Visits 1 and 2 (up to 2 weeks)]
• Research Burden [Time frame: Follow up Visit at Month 3 (week 15)]

Secondary outcome measures (1)

• Treatment Satisfaction [Time frame: 2-week follow-up (week 5)]

Eligibility criteria

Inclusion criteria

• Have a primary or secondary chronic masticatory muscle pain diagnosis
• Provide signed and dated electronic informed consent form
• Willing to comply with all study procedures
• Male or female, aged 18 or over
• Be able to speak and write in English
• Be seeking treatment at UKOPC
• Have the ability to perform telehealth visits (i.e., internet access, phone, tablet, computer or other device with audio/visual capabilities)

Exclusion criteria

• Currently using anticonvulsant, steroid, antispasmodic, or opioid medication for chronic pain 2 days a week or more often
• Have current or recent (within the last 3 months) psychotic, suicidal, homicidal, or manic symptoms. Participants with a history of such symptoms must demonstrate psychiatric stability for at least 6 months and be under the care of a medical or mental health professional for symptom management prior to being eligible for the study (must have written note from physician authorizing them to participate)
• Patients who are currently on medication for diabetes or seizures (i.e., epilepsy) must have written clearance from their medical providers prior to participating in the study
• History of seizures within the last 12 months
• Pain duration less than 3 months
• Pregnant or planning to become pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Kentucky — Lexington

Identifiers

NCT: NCT06357702 · 81313 · K23DE031807

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗