Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders

Not Applicable

Not yet recruiting

• Conditions: Temporomandibular Disorders (TMD); Nociplastic Pain; Aerobic Exercise; Strengthening Exercises; Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint

• Registration Number: NCT06584526
• Lead Sponsor: Universitat Internacional de Catalunya

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\'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:

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-09-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

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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 month

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Bilateral measure with digital algometer, applying a perpendicular pressure of 0.5 kg/cm2/s on: masseter, temporal, upper trapezius, SCOM, quadriceps tendon, achilles Tendon.

Secondary Outcome Measures

Name	Time	Method
Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post)	Baseline - 1 month (final) - 3 months	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 Strength at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Handgrip strength will be assessed with a Jamar dynamometer, maximal isometric strength, 2 times.; Maximal strength of upper trapezius, quadriceps and gastrocnemius will be assessed with a digital dynamometer ActivForce, maximal isometric strength, 2 times.; Before assessing strength, a 10 minutes warm up of the muscles will be done: * Upper trapezius: shoulder elevations; * Quadriceps: squat; * Gastrocnemius: heel elevations; * Handgrip: press a ball
Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device.
Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	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 Rest Heart Rate at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor.
Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	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 Sleep Quality at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)	Baseline - 6 weeks (final) - 12 weeks	Tampa Scale of Kinesiophobia: from 10 to 40 (Likert scale 4 points: 1 = totally disagree; 2 = disagree; 3 = agree; 4 = totally agree). Cut-off: 23.
Adherence at 6 weeks (final) and 12 weeks (post)	6 weeks (final) - 12 weeks	ATTEMPT questionnaire to evaluate adherence to exercises post-intervention. 6 items, Likert scale 5 punts ( 1 = totally disagree; 2 = disagree; 3 = neutral; 4 = agree; 5 = totally agree). From 6 to 30, a change of 4 indicates a change.