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

NCT05540366 | Unknown

• 1 other identifier: Flora Dantony
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)

  Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon

  Baseline - 2 weeks - 1 month (final) - 3 months

Secondary Outcomes (10)

• Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)

  Baseline - 2 weeks - 1 month (final) - 3 months post

• Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)

  Baseline - 2 weeks - 1 month (final) - 3 months posts

• Change of baseline in Jaw function at 1 month (final) and 3 months (post)

  Baseline - 1 month (final) - 3 months post

• Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)

  Baseline - 1 month (final) - 3 months posts

• Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)

  Baseline - 1 month (final) - 3 months post

Study Arms (2)

Intervention Group

EXPERIMENTAL

Myogenous temporomandibular subjects Physical 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.

Other: Physical therapy combined with aerobic exercise

Control group

ACTIVE COMPARATOR

Myogenous temporomandibular subjects Physical 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)

Other: Physical Therapy

Interventions

Physical therapy combined with 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 bike.

Intervention Group

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 intervention group)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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 months

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myofascial Pain Syndromes

Interventions

Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Flora Dantony

CONTACT

+34601533951; fdantony@uic.es

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: Physical therapy department

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 14, 2022
• Study Start: December 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)