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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoral Manual Therapy plus exercise and education. | Experimental | Six sessions of intraoral manual therapy plus exercise and counselling. |
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| Extraoral Manual Therapy plus exercise and education. | Experimental | Six sessions of extraoral manual therapy plus exercise and counselling. |
|
| Exercise and education. | Active Comparator | Exercise and counselling alone without any manual therapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral manual therapy | Other | Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Ballesteros Frutos, PhD student | Contact | 638332255 | jorgeballes10@gmail.com | |
| Jorge Ballesteros Frutos | Contact | +34 638 33 22 55 | jorgeballes10@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alcalá | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
| 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. |
|
| 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. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |