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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540366
• Other study ID #: Flora Dantony
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Universitat Internacional de Catalunya
• Contact: Flora Dantony
• Phone: +34601533951
• Email: fdantony[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• 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)

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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