K23- Physical Self Regulation vs Placebo
ConditionTemporomandibular Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIan Boggero, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Self Regulation Telehealth
Behavioral2 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.
Psycho-education Telehealth
Behavioral2 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 rate their stress levels, pain, and mood several times per day, similar to the times when participants in the PSR-TH condition would be practicing diaphragmatic breathing
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Physical Self RegulationExperimental treatment 1 intervention
Group B: Psycho-educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity
Pain intensity will be measured with the Graded Chronic Pain Scale Pain Intensity Subscale. Participants rate their worst pain, least pain, average pain, in the last 24 hours and pain right now using an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater pain. Scores are averaged for the total pain intensity score.
Time frame
Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)2
Change in pain interference
Pain interference will be measured with the The Graded Chronic Pain Scale Pain Interference Subscale. Participants rate how much the pain has interfered with 7 daily activities on an 11 point Likert scale ranging from 0 to 10 with higher scores equating to greater interference. Pain interference is scored as the mean of the 7 items.
Time frame
Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)3
Change in quality of life
Quality of life will be measured with the Satisfaction with Life Scale. Likert scale with 7 items scores range from 7 to 35 with higher scores equating to better quality of life.
Time frame
Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15)4
Recruitment rate
Number of patients who are consented into the study per month
Time frame
Baseline (week 0)Secondary outcomes
1
Treatment Satisfaction
Treatment Satisfaction Questionnaire 8 items on a 4 point Likert scale. Higher scores equate to greater satisfaction. Satisfaction is scored as mean of the 8 items.
Time frame
2-week follow-up (week 5)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ian Boggero, PhD
Lead sponsor
University of Kentucky
Sponsor institution
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
Source ClinicalTrials.gov