Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders
NCT Number: NCT06584526
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Disorders (TMD)|Nociplastic Pain|Aerobic Exercise|Strengthening Exercises|Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Sponsor: Universitat Internacional de Catalunya
Sex: ALL
Age: ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2025-07-31

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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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), 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, 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