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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
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This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism.
In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (muscle-energy technique) | Experimental | Mandibular muscle energy technique: In the supine position, the patient will open the mouth and perform isometric contractions for closure controlled by the physiotherapist. Passively, the physiotherapist will increase the range of mandibular opening. The technique consists of performing 3 sets, with 3 isometric contractions in each set of 3 seconds each. At the end of each set, the physiotherapist will passively try to gain mouth opening in order to continue the rest of the sets. At the end of all sets, gently return to the resting position. |
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| Control Group (sham technique) | Sham Comparator | Sham technique: In the supine position, the physiotherapist will place his hands under the patient's skull with the fingertips in contact with the suboccipital musculature for 5 minutes, without applying pressure or therapeutic intent. The objective is to provide a stimulus as similar as possible to the original Suboccipital Inhibition Technique, but without force of movement. The patient will keep the eyes closed for the duration of the technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle-energy mandibular technique | Procedure | A single session will be used with the mandibular musculoenergy technique. It will last approximately 2-3 minutes and will be performed by a physiotherapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in craniofacial pain intensity | For the subjective evaluation of craniofacial pain, the visual analog scale (VAS) will be applied. Scale from 0 (no pain at all) to 10 (maximum possible pain). | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mouth opening mobility | The active opening of the mouth will be measured using a digital caliper | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in rightward mandibular translation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Méndez-Sánchez, PhD | Contact | +34 923294500 | 3201 | ro_mendez@usal.es |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Méndez-Sánchez, PhD | University of Salamanca | Principal Investigator |
| Antonio Márquez-Vera, PT | Institute for Biomedical Research of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salamanca | Recruiting | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D002012 | Bruxism |
| D000092442 | Kinesiophobia |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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randomized, controlled, prospective, double-blind, clinical trial
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The participants will be blinded because in both groups they were following the treatment and medical recommendations and they will also be attended by a physiotherapist, in one case the mandibular muscular energy technique will be performed and in the other the placebo technique.
The evaluators did not know to which group the participants belonged.
| Sham technique | Procedure | A single session with a sham technique simulating the suboccipital muscle inhibition technique will be used. It will last approximately 2-3 minutes and will be performed by a physiotherapist. |
|
The active rightward mandibular translation will be measured using a digital caliper |
| 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in leftward mandibular translation | The active leftward mandibular translation will be measured using a digital caliper | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. |
| Changes in kinesiophobia | The Kinesiophobia will be recorded using the spanish version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S). It is a valid and reliable instrument for measuring kinesiophobia in patients with TMD, and it uses a Likert scale (1-4) containing 11 items in 2 domains, with higher scores indicating higher levels of kinesiophobia (0-44). | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. And a follow-up after one week |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D006184 | Habits |
| D001519 | Behavior |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |