Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial

University of Alcala1 site in 1 country90 target enrollmentApril 12, 2022

ConditionsTemporomandibular Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Temporomandibular Disorder
Sponsor: University of Alcala
Enrollment: 90
Locations: 1
Primary Endpoint: Change in pain intensity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.

Registry

clinicaltrials.gov

Start Date

April 12, 2022

End Date

November 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alcala

Responsible Party

Principal Investigator

Jorge Ballesteros Frutos

Principal Investigator

University of Alcala

Eligibility Criteria

Inclusion Criteria

•Unilateral temporomandibular pain for more than one month.
•Older than eighteen.
•No previous treatment to temporomandibular pain in the last 3 months.
•Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Exclusion Criteria

•Patients with cervical or cranial trauma or whiplash.
•Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
•Diagnosed of any vascular or metabolic disease.
•Previous cervical or temporomandibular surgery.
•Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.

Outcomes

Primary Outcomes

Change in pain intensity

Time Frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.

Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)

Secondary Outcomes

Change in pain pressure threshold(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
Change in range of movement of the temporomandibular joint(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
Change in quality of life(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
Change in disability(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)
Change in anxiety(Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.)