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

NCT06584526 | Completed

• 1 other identifier: FIS-2024-05
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post)

  Baseline - 1 month (final) - 3 months

• Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)

  Baseline - 6 weeks (final) - 12 weeks

• Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)

  Baseline - 6 weeks (final) - 12 weeks

• Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)

  Baseline - 6 weeks (final) - 12 weeks

• Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)

  Baseline - 6 weeks (final) - 12 weeks

Study Arms (3)

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: * Bilateral myofascial pressure of 60'' applied to the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles. * Dorsal glinding of the Occipital-Atlas segment, performed at Grade III intensity (3sets of 30'', with 15'' of rest). Therapeutic exercise: * Controlled opening and closing of the jaw: 6 repetitions with 30'' of rest * Isometric exercices of the jaw in opening, protrusion, and lateral excursion:3 sets of 10'' for each movement, 15'' of rest * Deep neck flexors training using StabilizerTM biofeedback, without contracting the superficial muscles: baseline pressure at 20 mmHg, perform craniocervical flexion at 22, 24, 26, 28, and 30 mmHg, 10'' per stage).

Other: Physical Therapy

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: * Warm-up: Participants cycled for 5 min at a heart rate reserve (HRR) of 50%. * Main work: For 24 min, participants performed an interval exercise divided into four intervals, with 4 min at 85%\* of the HRR and 2 min of recovery at 50-60% of the HRR in each cycle. * Active recovery: The last minute allowed participants to engage in active recovery at 50% of the HRR. \*: The value of the higher HHR will be reached through a weekly progression: * Week 1: 65% HHR * Week 2: 70% HHR * Week 3: 75% HHR * Week 4: 80% HHR * Week 5-6: 85% HHR 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.

Other: Physical Therapy and Aerobic Exercise

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: * Warm-up (5'): circuit, 3 sets of: jumping jacks (20''), mountain climbers (20''), abdominal crunch (20''), active stretching of the quadriceps (20''). * Main work: For 24 min, a circuit of multiarticular exercise (body weight). Four cycles of 4' of work, with 2' of rest between them. Each exercise will have a work time of 30'' guided with a timer. Intensity will be increased each 2 weeks (W) (higher difficulty and speed). * Lunge: W1-2 bilateral 10x / W3-4 unilateral 12x / W5-6 walking 14x * Push up: W1-2 inclined 8x / W3-4 normal 10x / W5-6 declined 10x * Squat: W1-2 normal 10x / W3-4 lateral lunge 12x / W5-6 step up 10x * Core: W1-2 front plank 10x / W3-4 up and down plank 12x / W5-6 superman 12x * Active recovery: Walk for 1'.

Other: Physical Therapy and Strength Exercise

Interventions

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).

Physical Therapy (PT)

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.

Physical Therapy and Aerobic Exercise (PT+AE)

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.

Physical Therapy and Strength Exercise (PT+ST)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, 08192, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Nociplastic Pain; Temporomandibular Joint Dysfunction Syndrome

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: September 9, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2024-09

Locations

ES (1)