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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the treatment Physical Self-Regulation for TMJ Dysfunction?

Research shows that physical self-regulation (PSR) can help manage chronic facial muscle pain by teaching skills like breathing and relaxation. Studies also suggest that PSR can reduce both physical and psychological symptoms of temporomandibular disorders by improving self-control and nervous system regulation. Additionally, PSR delivered via telehealth has been effective in increasing access to treatment for chronic pain. ^{1 2 3 4 5}

Is Physical Self-Regulation generally safe for humans?

Research on self-regulation techniques, like autogenic therapy and biofeedback, suggests they are generally safe and can help with stress management and relaxation. These methods are often used alongside other treatments and have been applied in various conditions without significant safety concerns. ^{6 7 8 9 10}

How is the Physical Self-Regulation Telehealth treatment for TMJ dysfunction different from other treatments?

This treatment is unique because it uses telehealth to teach self-regulation skills, like breathing and relaxation, to help manage TMJ dysfunction. It focuses on improving self-control and the body's automatic responses, which can reduce both physical and psychological symptoms. ^{1 2 3 4 5}

Research Team

Ian Boggero, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

New directions in the management of chronic pain: self-regulation theory as a model for integrative clinical psychology practice. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Self-regulation training for chronic pain: can it be done effectively by telemedicine? [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Physical self-regulation training for the management of temporomandibular disorders. [2015]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comprehensive rehabilitation of patients having chronic low back pain. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Sweden pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Biofeedback treatments of essential hypertension. [2019]

9. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

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