Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedStudy Start
First participant enrolled
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 14, 2024
May 1, 2024
4.4 years
November 22, 2021
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in pain intensity
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
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 Outcomes (5)
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.
Study Arms (3)
Intraoral Manual Therapy plus exercise and education.
EXPERIMENTALSix sessions of intraoral manual therapy plus exercise and counselling.
Extraoral Manual Therapy plus exercise and education.
EXPERIMENTALSix sessions of extraoral manual therapy plus exercise and counselling.
Exercise and education.
ACTIVE COMPARATORExercise and counselling alone without any manual therapy treatment.
Interventions
Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alcalá
Alcalá de Henares, Madrid, 28805, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 22, 2021
First Posted
December 22, 2021
Study Start
April 12, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share