Physical Self-Regulation for TMJ Dysfunction

Overseen By Courtney Brown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ian Boggero, PhD

Must not be taking: Anticonvulsants, Steroids, Antispasmodics, Opioids

Disqualifiers: Psychotic symptoms, Seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with chronic jaw muscle pain, also known as TMJ dysfunction. Participants will receive one of two telehealth treatments: a physical self-regulation session (Physical Self Regulation Telehealth) or a psycho-education session (Psycho-education Telehealth). Each treatment consists of two 50-minute sessions spaced about two weeks apart. The researchers aim to assess how these approaches affect pain control, coping, and relaxation. Individuals who have experienced jaw muscle pain for at least three months and seek treatment may be suitable candidates, provided they can attend telehealth appointments and are not regularly taking certain medications.

As an unphased trial, this study offers a unique opportunity to explore innovative treatments for TMJ dysfunction through telehealth.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. If you are using anticonvulsant, steroid, antispasmodic, or opioid medications for chronic pain more than twice a week, you cannot participate. Also, if you are on medication for diabetes or seizures, you need written clearance from your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that exercises and techniques to manage pain and improve jaw function in people with temporomandibular joint (TMJ) disorders are generally safe. Research indicates that participants in similar studies have handled the treatment well, with no serious side effects reported.

This approach, known as physical self-regulation, is not new. It has been used to manage TMJ disorders and is considered a non-invasive method. Participants in past studies experienced improvements in pain and jaw movement without major side effects.

While researchers continue to study this treatment, its history of use in similar conditions suggests it is safe and well-tolerated by most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Physical Self-Regulation for TMJ Dysfunction because it explores innovative telehealth methods that could make treatment more accessible and personalized. Unlike traditional treatments like medication or physical therapy that require in-person visits, these telehealth sessions offer a remote, convenient approach. The trial investigates two approaches: Physical Self Regulation, which focuses on techniques to manage pain and improve jaw function, and Psycho-education, providing support and information to help patients better understand their condition. This method could potentially empower patients to manage their symptoms more effectively from home, offering a new level of flexibility and control.

What evidence suggests that this trial's treatments could be effective for TMJ dysfunction?

Research shows that Physical Self-Regulation (PSR), which participants in this trial may receive, can help manage long-term facial muscle pain. Studies have found that PSR reduces this type of pain both in the short term and long term. PSR is a training program that teaches skills to handle pain better. It helps participants gain more control over their pain, boosts confidence, and improves coping strategies. These benefits are linked to better relaxation and fewer harmful habits. Overall, PSR seems promising for people with chronic facial pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Ian Boggero, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for patients seeking treatment for chronic pain in the jaw muscles, known as TMJ Dysfunction. Participants must be willing to receive therapy via telehealth and provide follow-up data after the sessions. Specific details on who can or cannot participate are not provided.

Inclusion Criteria

Provide signed and dated electronic informed consent form

Willing to comply with all study procedures

Be able to speak and write in English

Exclusion Criteria

I use medication for chronic pain at least 2 days a week.

I have been stable for 6 months after experiencing severe mental health symptoms and am under professional care.

I have diabetes or epilepsy and have gotten approval from my doctor to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two 50-minute telehealth sessions of either Physical Self-Regulation or a control intervention, approximately two weeks apart

4 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up data collected two weeks and three months after completing the interventions

11 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Physical Self Regulation Telehealth
• Psycho-education Telehealth

Trial Overview The study compares a brief behavioral intervention called Physical Self-Regulation (PSR) with a control intervention, both delivered through telehealth. Each participant receives two sessions of their assigned intervention, with follow-ups at two weeks and three months to assess feasibility and effectiveness.

How Is the Trial Designed?

Group I: Physical Self Regulation Experimental Treatment 1 Intervention

2 experimental telehealth sessions approximately 2 weeks apart

Group II: Psycho-education Active Control 1 Intervention

2 control telehealth sessions approximately 2 weeks apart

Physical Self Regulation Telehealth is already approved in United States for the following indications:

Approved in United States as Physical Self-Regulation for:

• Chronic masticatory muscle pain
• Chronic orofacial pain

Who Is Running the Clinical Trial?

Ian Boggero, PhD

Lead Sponsor

Trials

2

Recruited

120+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

Self-regulation theory can effectively enhance treatment for chronic pain, particularly in individuals with temporomandibular disorders, by promoting small behavioral changes that improve physiological factors related to pain.

An integrative clinical health psychology intervention focusing on physical self-regulation has been shown to reduce both physical and psychological symptoms in chronic pain patients by strengthening self-regulatory abilities and regulating the autonomic nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions in the management of chronic pain: self-regulation theory as a model for integrative clinical psychology practice. Sauer, SE., Burris, JL., Carlson, CR.[2011]

A brief skills training program in physical self-regulation (PSR) significantly reduced facial muscle pain and improved jaw function compared to standard dental care (SDC) at a 26-week follow-up, with participants reporting less pain and greater incisal opening.

Both PSR and SDC groups showed improvements in pain severity and life interference, but PSR demonstrated superior long-term benefits, suggesting that self-regulation strategies may be effective mechanisms for managing chronic facial muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical self-regulation training for the management of temporomandibular disorders. Carlson, CR., Bertrand, PM., Ehrlich, AD., et al.[2015]

The author summarizes 15 years of research on using self-regulatory techniques, specifically thermal biofeedback, to treat hypertension, highlighting the importance of patient expectations and home practice in achieving better outcomes.

A model is proposed that connects expectations, task performance, and biochemical variables, suggesting that these factors play a crucial role in the effectiveness of thermal biofeedback for managing high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatments of essential hypertension. Blanchard, EB.[2019]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

Patients with orofacial pain were significantly more likely to start (21.03% vs. 10.08%) and complete (odds ratio 5.69) a brief psychological intervention when offered via telehealth during the COVID-19 pandemic compared to in-person sessions before the pandemic.

The study suggests that telehealth may enhance patient engagement in psychological treatments for chronic pain, particularly for those in metropolitan areas, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Increases Access to Brief Behavioral Interventions in an Orofacial Pain Clinic During the COVID-19 Pandemic: A Retrospective Study. Sangalli, L., Fernandez-Vial, D., Moreno-Hay, I., et al.[2022]

The increasing incidence of stress-related disorders in children highlights the need for effective stress management techniques, which can be taught through hypnotherapy and biofeedback in primary care settings.

Hypnotherapy and biofeedback can help children develop self-regulation skills, leading to improved cognitive function and self-image, as demonstrated through case examples in the article.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Hypnosis and Biofeedback in Primary Care Pediatrics. Thomson, L.[2019]

Behavioral telemedicine interventions effectively teach self-regulation skills to chronic pain patients, showing promise as a treatment method for those who have not received prior treatment.

The study compared three delivery methods (face-to-face, telephone, and closed circuit TV) but noted limitations, such as the use of a single clinician for all interventions, which may affect the generalizability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation training for chronic pain: can it be done effectively by telemedicine? Appel, PR., Bleiberg, J., Noiseux, J.[2011]

A systematic review of 20 articles found that most adverse events (AEs) from manual therapy to peripheral joints were benign and transient, with only a few serious AEs reported, primarily related to acupuncture or massage.

The study highlights the need for awareness of potential risks associated with various manual therapy techniques, but overall, serious adverse events are rare, suggesting that manual therapy is generally safe for treating peripheral joint issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with manual therapy of peripheral joints: A scoping review. Sheldon, A., Karas, S.[2022]

In a study involving 72 patients with chronic back pain, a comprehensive self-regulation program led to significant improvements, with 57 patients achieving unimpaired physical functioning levels by discharge after an average stay of 45 days.

Additionally, 59 patients reached success in vocational restoration, indicating that the self-regulation approach not only helped with physical recovery but also supported patients in returning to work or training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive rehabilitation of patients having chronic low back pain. Gottlieb, H., Strite, LC., Koller, R., et al.[2009]

Autogenic therapy enhances self-regulatory capacity through exercises that promote muscle relaxation and improve physiological responses such as increased blood flow and reduced heart rate.

This therapy is beneficial for various stress-related conditions and can serve as a preventive measure or complement to traditional medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Free from stress by autogenic therapy. Relaxation technique yielding peace of mind and self-insight]. Broms, C.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11889647/

Physical self-regulation training for the management of ... Conclusion: The findings support the use of PSR for the short- and long-term management of muscle pain in the facial region. These results are discussed in ...

2. files.jofph.com files.jofph.com/files/article/20240104-26/pdf/jop_15_1_carlso4.pdf

Physical Self-Regulation Training for the Management of ... Aims: To evaluate the long-term effectiveness of a brief skills training program for the management of chronic facial muscle pain. This program of physical self ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04819763

Physical Exercises for Temporomandibular Disorders The aim of this study is to examine the effectiveness of muscle training for the treatment of patients with anterior disc displacement with reduction (DDWR).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266435620304599

Outcomes of physical therapy in patients with ... This study further explores if physical therapy is an effective approach to treating patients with TMJ disorders.

5. researchgate.net researchgate.net/publication/11472975_Physical_Self-Regulation_Training_for_the_Management_of_Temporomandibular_Disorders

Physical Self-Regulation Training for the Management of ... To evaluate the long-term effectiveness of a brief skills training program for the management of chronic facial muscle pain.

6. journalomp.org journalomp.org/journal/view.html?doi=10.14476/jomp.2022.47.4.174

Management of Chronic Pain in Temporomandibular ... Physical self-regulation training for the management of temporomandibular disorders. J Orofac Pain 2001;15:47-55. Wright EF, Domenech MA ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1882761625000171

The effectiveness of mobilization in treating patients with ... The self-report questionnaires, including Jaw function limitation scale (JFLS), Temporomandibular joint dysfunction disability index (TDI), Tampa scale of ...