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NCT Number: NCT06584526

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

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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Aerobic Exercise Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Myofascial Pain Syndromes Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Strengthening Exercises Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, 08192, Spain

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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 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.

Primary outcomes

  1. Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: Baseline - 6 weeks (final) - 12 weeks

    Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device.

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

    Time frame: 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)

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

    Time frame: Baseline - 6 weeks (final) - 12 weeks

    Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor.

  6. Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post)

    Time frame: 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)

  7. Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)

    Time frame: Baseline - 6 weeks (final) - 12 weeks

    Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.

  8. Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)

    Time frame: 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.

  9. Adherence at 6 weeks (final) and 12 weeks (post)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Effects of Aerobic and Strength Exercice on Nociplastic Pain in Patients With Temporomandibular Disorders: A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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