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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06584526
Enrollment
51
Registered
2024-09-04
Start date
2024-09-09
Completion date
2025-09-30
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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:

Interventions

OTHERPhysical 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).

OTHERPhysical 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.

OTHERPhysical 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.

Sponsors

Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksBilateral 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

MeasureTime frameDescription
Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post)Baseline - 1 month (final) - 3 monthsFonseca 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.
Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksHandgrip 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
Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksAssessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device.
Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksCentral Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksPatient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor.
Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksHospital 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)
Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksPittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)Baseline - 6 weeks (final) - 12 weeksTampa Scale of Kinesiophobia: from 10 to 40 (Likert scale 4 points: 1 = totally disagree; 2 = disagree; 3 = agree; 4 = totally agree). Cut-off: 23.
Adherence at 6 weeks (final) and 12 weeks (post)6 weeks (final) - 12 weeksATTEMPT 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026