Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Study Overview
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Brief Summary
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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.

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

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Other: Intraoral manual therapy
* Other: Extraoral manual therapy
* Other: Exercise and counselling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoral Manual Therapy plus exercise and education.<br>Six sessions of intraoral manual therapy plus exercise and counselling. | Other: Intraoral manual therapy<br>* Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.<br>Other: Exercise and counselling<br>* 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.<br>|
| Experimental: Extraoral Manual Therapy plus exercise and education.<br>Six sessions of extraoral manual therapy plus exercise and counselling. | Other: Extraoral manual therapy<br>* Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.<br>Other: Exercise and counselling<br>* 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.<br>|
| Active Comparator: Exercise and education.<br>Exercise and counselling alone without any manual therapy treatment. | Other: Exercise and counselling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain pressure threshold | Pain pressure threshold measured by a digital algometer at several locations of 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 range of movement of the temporomandibular joint | Active and passive range of movement measured by a digital caliper. | 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 | 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). | 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 | Disability measured with Craniofacial Pain and Disability Inventory (CF-PDI). CF-PDI ranges from 0 (better functional status) to 63 (worse 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 | Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater 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. |