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

NCT ID: NCT06584526

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-07-31

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:

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy (PT)

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).

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: 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 and Aerobic Exercise (PT+AE)

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.

Group Type: EXPERIMENTAL

Physical Therapy and Aerobic Exercise

Intervention Type: 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 Strength Exercise (PT+ST)

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'.

Group Type: EXPERIMENTAL

Physical Therapy and Strength Exercise

Intervention Type: 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.

Interventions

Physical Therapy

30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups).

Intervention Type: OTHER

Physical Therapy and Aerobic Exercise

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.

Intervention Type: OTHER

Physical Therapy and Strength Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Flora Dantony

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, Spain

Countries

Spain

Central Contacts

Flora Dantony, Physical Therapist, Msc

Role: CONTACT

fdantony@uic.es

+34601533951

Facility Contacts

Flora Dantony, PT, Msc

Role: primary

fdantony@uic.es

+34601533951

Other Identifiers

FIS-2024-05

Identifier Type: -

Identifier Source: org_study_id