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Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization

Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05540366
Enrollment
20
Registered
2022-09-14
Start date
2022-12-01
Completion date
2023-06-30
Last updated
2023-01-27

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

Conditions

Central Sensitisation, Endurance Training, Myofascial Pain Syndrome, Temporomandibular Disorder

Brief summary

Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.

Interventions

OTHERPhysical therapy combined with 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 bike.

OTHERPhysical Therapy

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

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 No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist. * A minimum score of 30 in the Central Sensitization Index * Positive FRT

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 months

Design outcomes

Primary

MeasureTime frameDescription
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)Baseline - 2 weeks - 1 month (final) - 3 monthsBilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon

Secondary

MeasureTime frameDescription
Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)Baseline - 2 weeks - 1 month (final) - 3 months postCentral Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Change of baseline in Jaw function at 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postFonseca 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 Jaw range of motion al 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postsMillimeter metalic rule to assess opening, lateral and protrusion jaw range of motion
Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postCROM for global cervical range (flexion, extension, rotations, inclinations)
Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)Baseline - 2 weeks - 1 month (final) - 3 months postsVisual Analog Scale: 100mm (no pain to worst pain)
Change of baseline in Neck disability at 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postsNeck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete)
Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postsHospital 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 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postsPittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Change of baseline in Perceived change at 1 month (final) and 3 months (post)Baseline - 1 month (final) - 3 months postsGlobal Rating of Change scale: 15 points, from -7 (worst) to 7 (best)
Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)Baseline - 2 weeks - 1 month (final) - 3 months postsAssessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device

Countries

Spain

Contacts

Primary ContactFlora Dantony
fdantony@uic.es+34601533951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026