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Recruiting NCT05167656

Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

No phase Interventional Temporomandibular Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoral manual therapy, Extraoral manual therapy, Exercise and counselling.
Who it may be relevant to
Registry conditions: Temporomandibular Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Intraoral manual therapy
    Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
  • Other Extraoral manual therapy
    Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
  • Other Exercise and counselling
    Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders. Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching. Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Primary outcome measures

  • 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.]
Secondary outcome measures (5)
  • Change in pain pressure threshold [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.]
  • Change in range of movement of the temporomandibular joint [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.]
  • Change in quality of life [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.]
  • Change in disability [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.]
  • Change in anxiety [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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • University of Alcalá — Alcalá de Henares

Identifiers

NCT: NCT05167656 · CEID/2021/4/087

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗