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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorder; Myofascial Pain Syndrome; Central Sensitisation; Endurance Training
• Intervention / Treatment: Other: Physical therapy combined with aerobic exercise; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flora Dantony; Phone Number: +34601533951; Email: fdantony@uic.es

Study Locations

• Spain
  • Sant Cugat Del Vallès, Spain
    • Recruiting
    • Universitat Internacional de Catalunya
    • Contact: Flora Dantony

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
Active Comparator: Control group; 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; 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Flora Dantony

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No