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

Not Applicable

Recruiting

• Conditions: Temporomandibular Disorder; Central Sensitisation; Myofascial Pain Syndrome; Endurance Training
• Interventions: Other: Physical Therapy; Other: Physical therapy combined with aerobic exercise

• Registration Number: NCT05540366
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Study Start: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Physical Therapy	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)
Intervention Group	Physical therapy combined with aerobic exercise	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Spain