What side effects are associated with this type of intervention?

Common treatments for Temporomandibular Joint Disorder (TMD), such as therapeutic exercises and neuromodulation techniques like Motor Control Training using Visual Feedback (MCTF), may cause temporary muscle soreness, fatigue, and mild discomfort. Neuromodulation techniques, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), can lead to mild headaches, scalp discomfort, and tingling sensations. These side effects are typically mild and short-lived.

What prior FDA approvals exist?

The FDA has approved various treatments for Temporomandibular Joint Disorder (TMD), primarily focusing on pain relief and improving function. While specific FDA approvals for treatments like Motor Control Training using Visual Feedback (MCTF) are not detailed, related neuromodulation therapies such as transcutaneous electrical nerve stimulation (TENS) and other non-invasive brain stimulation techniques have been explored for their potential in pain modulation and brain plasticity. These treatments aim to alleviate pain and improve muscle function, aligning with the goals of MCTF in targeting cortical changes to enhance clinical outcomes.

What other types of research exist?

Promising novel alternatives to MCTF for TMD patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in modulating brain activity and reducing pain in various conditions, 2) Haptic Adaptive Feedback integrated with robotic exoskeletons, which promotes motor learning and may enhance corticospinal excitability, and 3) Guided Imagery and Progressive Muscle Relaxation, which have been effective in reducing pain and improving function in other musculoskeletal conditions. These alternatives offer different mechanisms of action and could be considered based on individual patient needs and responses.

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Neck Exercises for TMJ Dysfunction

N/A

Waitlist Available

Led By Susan Armijo-Olivo, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females 18-60 years of age diagnosed with muscle pain disorders as classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) or mixed TMD

Have had pain in the masticatory muscle for at least 3 months

Must not have

Psychiatric disorders (e.g., depression, schizophrenia)

Previous experience with electrotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 2 months ( change from baseline at 6 months )

Summary

This trial tests if specific neck exercises with visual feedback can help women with chronic jaw pain. The exercises aim to improve muscle control and reduce pain by potentially reversing brain changes linked to chronic pain. The study will measure pain levels, brain changes, and muscle function before and after the exercise program.

Who is the study for?

This trial is for women aged 18-60 with chronic muscle pain in the jaw, diagnosed as TMD. They must have had this pain for at least 3 months and a moderate to severe pain level. Excluded are those with certain diseases like rheumatoid arthritis, psychiatric disorders, abnormal neurological exams, MRI contraindications (like metal implants), substance abuse history, recent exercise therapy or electrotherapy experience, and pregnant or planning pregnancy.

What is being tested?

The study tests if neck exercises can help women with TMD by reducing pain and improving jaw function. It involves comparing motor control training using visual feedback against a placebo (inactive treatment). Participants will be randomly assigned to either the active exercise group or the placebo group and tracked over time to see changes in their condition.

What are the potential side effects?

Since this trial involves physical exercises and a placebo that's turned off electrical nerve stimulation, side effects might include typical exercise-related discomfort such as muscle soreness or strain. The placebo is expected not to cause any side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18-60 with diagnosed muscle pain in my jaw or face.

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I have had jaw muscle pain for at least 3 months.

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My pain level is moderate or severe, scoring 30 or more on a 100 mm scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed psychiatric condition like depression or schizophrenia.

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I have undergone electrotherapy before.

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I have abnormal results from my neurological exam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 2 months (change from baseline at 6 months (if budget allows))

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 2 months (change from baseline at 6 months (if budget allows))

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 2 months (change from baseline at 6 months (if budget allows)) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fractional Anisotropy (FA)

Pain Intensity measured with a Visual Analogue Scale (VAS)

functional brain networks

Secondary study objectives

Craniocervical Flexion Test (CCFT)

Global Rating Scale (GRS)

Jaw function

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExercisesExperimental Treatment1 Intervention

Neck flexors Training: Each patient will initially perform cranio-cervical flexion to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the contraction duration will be increased to 10 s, and the participant trained to perform 10 repetitions with brief rest periods between each contraction. Once one set of 10 repetitions of 10 s is achieved at one target level, the exercise will be progressed to train at the next target level up to the final target. Neck extensors training: Patients will perform cranio-cervical extension and upper cervical rotation in a prone on elbows position while maintaining the cervical spine in a neutral position, progressing to a 4-pt kneeling position.

Group II: PlaceboPlacebo Group1 Intervention

The placebo group will receive placebo TENS (switched-off TENS apparatus with no perceptible stimulation). Four electrodes, 50 x 35 mm, will be placed on the neck muscles. The participant will be informed that this therapy is called a "subthreshold current" and they might not be able to feel any sensation underneath the electrodes during the treatment. The placebo treatment will be for 30 min twice a week for 8 weeks, as for the intervention group.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Temporomandibular Joint Disorder (TMD) often involve therapeutic exercises aimed at improving motor control and reducing pain. Motor Control Training using Visual Feedback (MCTF) is a specific approach that targets brain plasticity and pain modulation. This method involves exercises that enhance the coordination and strength of the cervical muscles, which can lead to structural and functional changes in the brain. These changes are believed to help reduce pain intensity and improve jaw function. For TMD patients, these mechanisms are crucial as they address both the physical and neurological aspects of the disorder, potentially leading to more effective and long-lasting relief from symptoms.

The use of transcranial magnetic stimulation as a treatment for movement disorders: A critical review.Contralesional motor cortex is causally engaged during more dexterous actions of the paretic hand after stroke-A Preliminary report.The role of motor neuron drive in muscle fatigue.