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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 )
Awards & highlights

Summary

This trial will study the impact of therapeutic exercise on women with chronic pain due to temporomandibular disorders. The goal is to improve pain and function.

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.Check my eligibility
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.See study design
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.
Select...
I have undergone electrotherapy before.
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I have abnormal results from my neurological exam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 2 months ( change from baseline at 6 months )
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 2 months ( change from baseline at 6 months ) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fractional Anisotropy (FA)
Pain Intensity measured with a Visual Analogue Scale (VAS)
functional brain networks
Secondary outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
901 Previous Clinical Trials
387,437 Total Patients Enrolled
Susan Armijo-Olivo, PhDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

Neck Exercises Clinical Trial Eligibility Overview. Trial Name: NCT03403998 — N/A
Temporomandibular Joint Disorder Research Study Groups: Exercises, Placebo
Temporomandibular Joint Disorder Clinical Trial 2023: Neck Exercises Highlights & Side Effects. Trial Name: NCT03403998 — N/A
Neck Exercises 2023 Treatment Timeline for Medical Study. Trial Name: NCT03403998 — N/A
~7 spots leftby Dec 2024