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NCT Number: NCT05167656

Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location status: Recruiting

Location contact

Jorge Ballesteros, PhD Student

CONTACT

[email protected]

638332255

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoral manual therapy

Other

Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.

Extraoral manual therapy

Other

Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.

Exercise and counselling

Other

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 outcomes

  1. 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

  1. 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.

    Pain pressure threshold measured by a digital algometer at several locations of temporomandibular joint.

  2. 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.

    Active and passive range of movement measured by a digital caliper.

  3. 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.

    Quality of life measured with Short Form Health Survey (SF-12). SF-12 ranges from 0 (poor quality of life) to 100 (great quality of life).

  4. 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.

    Disability measured with Craniofacial Pain and Disability Inventory (CF-PDI). CF-PDI ranges from 0 (better functional status) to 63 (worse disability).

  5. 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.

    Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety).

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Ballesteros Frutos

CONTACT

[email protected]

+34 638 33 22 55

Jorge Ballesteros Frutos, PhD student

CONTACT

[email protected]

638332255

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2021
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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