K23- Physical Self Regulation vs Placebo

Launched by IAN BOGGERO, PHD · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Physical Self-Regulation for people suffering from chronic pain in their jaw muscles, known as Temporomandibular Disorder (TMD). Participants will be randomly placed into two groups: one will receive the Physical Self-Regulation intervention, and the other will receive a control treatment, both through telehealth sessions that last about 50 minutes each, scheduled two weeks apart. Researchers want to see how well these treatments work and whether they help improve patients' control over their pain and overall coping skills.

To be eligible for the study, participants must be at least 18 years old and have a diagnosis of chronic jaw muscle pain. They should also be willing to attend telehealth visits and be able to communicate in English. However, individuals who are currently taking certain pain medications, have recent severe mental health issues, or are pregnant cannot participate. After the sessions, participants will be contacted two weeks and three months later to check on their progress. This study aims to understand how these treatments might help manage pain and improve quality of life for those affected by TMD.

Gender

ALL

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