Clinical trial NCT06584526: Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders
Official title: Effects of Aerobic and Strength Exercice on Nociplastic Pain in Patients with Temporomandibular Disorders: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Nociplastic Pain
Aerobic Exercise
Strengthening Exercises
Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic and strength exercises showed to be effective in subjects with chronic pain and nociplastic pain, by inducing an hypoalgesic effect. However, there isn\&#39;t investigation about the effects of theses types of exercise in subjects with temporomandibular disorders and nociplastic pain. Thus, the aim of the study is to determine if adding aerobic or strength exercise to an effective physical therapy programme is more effective than physical therapy alone to improve nociplastic pain in subjects with temporomandibular disorders.

Detailed description: Introduction: Temporomandibular disorders used to improve with education manual therapy and therapeutic exercise. However, despite the evidence oh nociplastic pain in these patients, the treatments remain local. As aerobic and strength exercice have hypoalgesic effect in chronic musculoskeletal pain, we aim to study the effects combined with a common physical therapy programme on nociplastic pain in patients with temporomandibular disorders.

Main objective: Determine if aerobic exercice and strength exercice combined with physical therapy are more effective than physical therapy alone to improve local and remote pressure pain threshold (temporals, masseters, sternocledomastoids, upper trapezius, handgrip, quadriceps and gastrocnemius), in subjects with temporomandibular disorders and nociplastic pain.

Material and methodos:

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
* Chronic pain (\&gt;3months)
* Nociplastic pain
* Positive Flexion Rotation Test
* Be physically able to realize aerobic and strength exercise (functional movement test)

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 month

Primary outcomes:
measure: Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
Secondary outcomes:
measure: Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 1 month (final) - 3 months
measure: Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)
timeFrame: Baseline - 6 weeks (final) - 12 weeks
measure: Adherence at 6 weeks (final) and 12 weeks (post)
timeFrame: 6 weeks (final) - 12 weeks
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalunya
Study officials:
References: