Clinical trial NCT05540366: Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization
Official title: Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Central Sensitisation
Myofascial Pain Syndrome
Endurance Training
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)
timeFrame: Baseline - 2 weeks - 1 month (final) - 3 months
Secondary outcomes:
measure: Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)
timeFrame: Baseline - 2 weeks - 1 month (final) - 3 months post
measure: Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)
timeFrame: Baseline - 2 weeks - 1 month (final) - 3 months posts
measure: Change of baseline in Jaw function at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months post
measure: Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months posts
measure: Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months post
measure: Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)
timeFrame: Baseline - 2 weeks - 1 month (final) - 3 months posts
measure: Change of baseline in Neck disability at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months posts
measure: Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months posts
measure: Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months posts
measure: Change of baseline in Perceived change at 1 month (final) and 3 months (post)
timeFrame: Baseline - 1 month (final) - 3 months posts
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
Study officials:
References: