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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy (PT) | Active Comparator | 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups). Education: a series of recommendations to correct inappropriate behaviors such as parafunctions. Manual therapy:
Therapeutic exercise:
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| Physical Therapy and Aerobic Exercise (PT+AE) | Experimental | Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes aerobic exercise programme on a cycle ergometer. The AE will consist of:
The HRR was calculated using the Karvonen formula used in similar studies: HRtarget = [HHR x %intensity] + HRrest HRR = HRmax - HRrest HRmax = 207 - (0.7 x age) HR assessed with a Polar10 sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Other | 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post) | 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. | Baseline - 6 weeks (final) - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (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 |
| Change of baseline in Strength at 6 weeks (final) and 12 weeks (post) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Sant Cugat del Vallès | Catalonia | 08192 | Spain |
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| Physical Therapy and Strength Exercise (PT+ST) | Experimental | Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes strength exercise (ST) programme. The ST exercise will consist of:
|
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| Physical Therapy and Aerobic Exercise | Other | 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 cycle ergometer. |
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| Physical Therapy and Strength Exercise | Other | 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes strength exercise programme. |
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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:
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| Baseline - 6 weeks (final) - 12 weeks |
| Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post) | Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device. | Baseline - 6 weeks (final) - 12 weeks |
| Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post) | Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem) | Baseline - 6 weeks (final) - 12 weeks |
| Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post) | Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor. | Baseline - 6 weeks (final) - 12 weeks |
| Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (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 - 6 weeks (final) - 12 weeks |
| Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post) | Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point. | Baseline - 6 weeks (final) - 12 weeks |
| Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post) | 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. | Baseline - 6 weeks (final) - 12 weeks |
| Adherence at 6 weeks (final) and 12 weeks (post) | 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. | 6 weeks (final) - 12 weeks |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D000098653 | Nociplastic Pain |
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009209 | Myofascial Pain Syndromes |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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