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Neck Exercises for TMJ Dysfunction

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,064 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still enrolling participants?

"According to the clinicaltrials.gov database, this research endeavour is presently seeking participants; it was opened for recruitment on January 17th 2018 and last updated on July 7th 2022."

Answered by AI

Does this research involve participants 55 years of age or younger?

"This clinical trial requests that participants are between 18 and 60 years of age. For those under the legal age as well as elderly individuals, there are 257 and 666 studies respectively available to them."

Answered by AI

To what extent is participation being sought for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov website, this investigation is recruiting participants right now; it was first published on January 17th 2018 and most recently revised on July 7th 2022. Approximately 70 people need to be recruited from one location for this study's completion."

Answered by AI

What results are anticipated from this clinical trial?

"The primary outcome measure of this trial is the alteration of functional brain networks at 6 months (if budget allows). Secondary quantitative outcomes include Neck Extensor Endurance Test, Global Rating Scale, and Psychological Functioning: Depression; all assessed via PHQ-9. Additionally, participants will be asked to rate their change in jaw pain and function using a 15-point Likert scale."

Answered by AI

What are the criteria for eligibility in this experiment?

"This trial involves 70 individuals aged 18 to 60 experiencing temporomandibular disorders. To be considered for participation, participants must have persistent muscle pain in the jaw that is a result of neither recent trauma nor active inflammation and has lasted at least 3 months."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neck Exercises in Patients With Temporomandibular Disorders

susan armijo olivo 2018. "Neck Exercises in Patients With Temporomandibular Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03403998.

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