Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization

Study Overview
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Brief Summary
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Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.

Official Title
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Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial

Conditions
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Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome, Endurance Training

Intervention / Treatment
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* Other: Physical therapy combined with aerobic exercise
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist. A minimum score of 30 in the Central Sensitization Index Positive FRT Exclusion Criteria: History of trauma, TMJ or cervical fracture the past three months History of TMJ or cervical surgery Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant History of cardiovascular diseases which contraindicate aerobic exercise Current orthodontic treatment, splints for bruxism Drug addiction, alcoholism Pregnancy Use of analgesic medication less than 48 hours before each data collection Physical therapy treatment during the past three months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Myogenous temporomandibular subjects Physical therapy combined with aerobic exercise: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike. | Other: Physical therapy combined with aerobic exercise<br>* 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike.<br>|
| Active Comparator: Control group<br>Myogenous temporomandibular subjects Physical Therapy: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group) | Other: Physical Therapy<br>* 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post) | Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon | Baseline - 2 weeks - 1 month (final) - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post) | Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem) | Baseline - 2 weeks - 1 month (final) - 3 months post | 
| Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post) | Visual Analog Scale: 100mm (no pain to worst pain) | Baseline - 2 weeks - 1 month (final) - 3 months posts | 
| Change of baseline in Jaw function at 1 month (final) and 3 months (post) | Fonseca Anamnestic Index. 10 questions with a three-point scale: 0 = no, 5 = sometimes and 10 = yes; total score from 0 good function, to 100 worst. | Baseline - 1 month (final) - 3 months post | 
| Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post) | Millimeter metalic rule to assess opening, lateral and protrusion jaw range of motion | Baseline - 1 month (final) - 3 months posts | 
| Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post) | CROM for global cervical range (flexion, extension, rotations, inclinations) | Baseline - 1 month (final) - 3 months post | 
| Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post) | Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device | Baseline - 2 weeks - 1 month (final) - 3 months posts | 
| Change of baseline in Neck disability at 1 month (final) and 3 months (post) | Neck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete) | Baseline - 1 month (final) - 3 months posts | 
| Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post) | Hospital Anxiety and Depression Scale: 2 subscales, one for anxiety and the other one for depression. Each scale score is from 0 (less) to 21 (worst) | Baseline - 1 month (final) - 3 months posts | 
| Change of baseline in Sleep Quality at 1 month (final) and 3 months (post) | Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point. | Baseline - 1 month (final) - 3 months posts | 
| Change of baseline in Perceived change at 1 month (final) and 3 months (post) | Global Rating of Change scale: 15 points, from -7 (worst) to 7 (best) | Baseline - 1 month (final) - 3 months posts |