Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05167656

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

Led by University of Alcala · Updated on 2024-05-14

90

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of intraoral manual therapy compared to extraoral manual therapy and a control group in adults with temporomandibular disorders. The study aims to assess how these therapies impact pain, strength, quality of life, disability, and anxiety in patients experiencing unilateral temporomandibular pain lasting more than one month. This randomized controlled trial is led by the University of Alcala and includes adults aged 18 to 75 years. Participants will be randomly assigned to one of three groups: six sessions of intraoral manual therapy combined with exercise and counseling, six sessions of extraoral manual therapy combined with exercise and counseling, or exercise and counseling alone without manual therapy. The manual therapies involve techniques such as ischemic compression and pain pressure release applied to the muscles around the temporomandibular joint. The exercise and counseling program includes education on contributing factors and daily exercises focused on joint mobility, stretching, and self-massage. Throughout the study, participants will be evaluated at multiple time points including baseline, 3 weeks, 6 weeks, 1 month, 3 months, and 6 months after treatment. Assessments include pain intensity, pain pressure threshold, range of motion of the temporomandibular joint, quality of life, disability, and anxiety. These measures will help determine the effects of the therapies over time. The total duration of participation varies up to six months after treatment completion, with ongoing monitoring of changes in symptoms and function.

CONDITIONS

Brief Title

Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral temporomandibular pain lasting more than one month
  • Age 18 to 75 years
  • No treatment for temporomandibular pain in the last 3 months
  • Diagnosis based on Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Not Eligible

You will not qualify if you...

  • History of cervical or cranial trauma or whiplash
  • Diagnosis of systemic diseases such as rheumatoid arthritis or fibromyalgia
  • Diagnosis of any vascular or metabolic disease
  • Previous cervical or temporomandibular surgery
  • Any dental, medical, or physical therapy treatment in the last 3 months before starting interventions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 weeks

Participants receive six sessions of either intraoral manual therapy plus exercise and counselling, extraoral manual therapy plus exercise and counselling, or exercise and counselling alone without manual therapy.

6 therapy sessions plus daily exercise program

Follow-up

Duration - 6 months post-treatment

Participants are followed to assess changes in pain intensity, pain pressure threshold, range of movement, quality of life, disability, and anxiety up to 6 months after treatment.

Visits at 1 month, 3 months, and 6 months after treatment

Trial Site Locations

Total: 1 location

1

University of Alcalá

Alcalá de Henares, Madrid, Spain, 28805

Actively Recruiting

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Research Team

J

Jorge Ballesteros Frutos, PhD student

J

Jorge Ballesteros Frutos

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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