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Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.
Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visceral manual treatment | Experimental | The objective of this technique is to reduce the tension of the tissues of the epigastric area. |
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| Respiratory listening | Active Comparator | It is a maneuver to evaluate the mobility of the ribs during respiration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visceral manual treatment | Procedure | The patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure pain threshold (PPT) Baseline-1 | The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention |
| PPT Change-1 | The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "PTT Baseline-1" immediately post-intervention |
| PPT Baseline-2 | The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention at 7 days |
| PPT Change-2 | The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "PTT Baseline-2" immediately post-intervention |
| PPT Change-3 | The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Range of Motion (CROM) Baseline-1 | The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lourdes M Fernández Seguín, PhD | Contact | 630258773 | +34 | lfdez@us.es |
| Cayetano Navarro Rico, Phd Student | Contact | 664894442 | +34 | cayetanonavarro95@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lourdes M Fernández Seguín, PhD | University of Seville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursing, Physiotherapy and Podiatry Faculty | Recruiting | Seville | Spain | 41009 | Spain |
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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| Respiratory listening | Procedure | The patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage. |
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| Change from "PTT Baseline-2" and "PTT Change-2" at 1 month |
| Heart Rate Variability (HRV) Baseline-1 | Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position. | Baseline pre-intervention |
| HRV Change-1 | Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position. | Change from "HRV baseline-1" inmediately post-intervention |
| HRV Baseline-2 | Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position. | Baseline pre-intervention at 7 days |
| HRV Change-2 | Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position. | Change from "HRV baseline-2" inmediately post-intervention |
| HRV Change-3 | Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position. | Change from "HRV baseline-2" and "HRV change-2" at 1 month |
| Myotonometry baseline-1 | The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention |
| Myotonometry change-1 | The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "myotonometry baseline-1" inmediately post-intervention |
| Myotonometry baseline-2 | The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention at 7 days |
| Myotonometry change-2 | The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "myotonometry baseline-2" inmediately post-intervention |
| Myotonometry change-3 | The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month |
| Cervical Range of Motion (CROM) Change-1 | The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "CROM Baseline-1" immediately post-intervention |
| Cervical Range of Motion (CROM) Baseline-2 | The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention at 7 days |
| Cervical Range of Motion (CROM) Change-2 | The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "CROM Baseline-2" immediately post-intervention |
| Cervical Range of Motion (CROM) Change-3 | The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "CROM Baseline-2" and "CROM Change-2" at 1 month |
| Perceived Stress Scale (PSS-14) Baseline | Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress. | Baseline |
| PSS-14 Change | Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress. | Change from Baseline PSS-14 at 1 month |
| Mandibular Mobility Baseline-1 | For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention |
| Mandibular Mobility Change-1 | For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "Mandibular Mobility Baseline-1" immediately post-intervention |
| Mandibular Mobility Baseline-2 | For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Baseline pre-intervention at 7 days |
| Mandibular Mobility Change-2 | For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "Mandibular Mobility Baseline-2" immediately post-intervention |
| Mandibular Mobility Change-3 | For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3. | Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month |
| Pittsburgh Sleep Quality Index (PSQI) Baseline | It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers. | Baseline |
| PSQI Change | It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers. | Change from Baseline PSQI at 1 month |