Effectiveness of Visceral Manual Therapy in Bruxist Patients

NCT05751694 | Recruiting DMC

• 1 other identifier: 070223TDCNR
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruxism

Keywords

Bruxism; Musculoskeletal Manipulations; Physical Therapy Modalities; Autonomic Nervous System

Outcome Measures

Primary Outcomes (15)

• 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.

  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

Secondary Outcomes (14)

• Cervical Range of Motion (CROM) Baseline-1

  Baseline pre-intervention

• Cervical Range of Motion (CROM) Change-1

  Change from "CROM Baseline-1" immediately post-intervention

• Cervical Range of Motion (CROM) Baseline-2

  Baseline pre-intervention at 7 days

• Cervical Range of Motion (CROM) Change-2

  Change from "CROM Baseline-2" immediately post-intervention

• Cervical Range of Motion (CROM) Change-3

  Change from "CROM Baseline-2" and "CROM Change-2" at 1 month

Study Arms (2)

Visceral manual treatment

EXPERIMENTAL

The objective of this technique is to reduce the tension of the tissues of the epigastric area.

Procedure: Visceral manual treatment

Respiratory listening

ACTIVE COMPARATOR

It is a maneuver to evaluate the mobility of the ribs during respiration.

Procedure: Respiratory listening

Interventions

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.

Visceral manual treatment

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.

Respiratory listening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with bruxism diagnosed and referred by a dentist
• Age: older than 18 years-old.

You may not qualify if:

• Recent craniofacial, mandibular or cervical trauma or fracture.
• Temporomandibular joint surgery.
• Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
• Abdominal surgery.
• Gastric ulcers.
• Gastritis.
• Previous or current gastric neoplasm.
• Neurological or systemic diseases.
• Pregnant, including the period of breastfeeding.
• Patients receiving chemotherapy or radiotherapy.
• Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
• Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
• Cerebrovascular and brain diseases.
• Arrhythmia and other cardiac problems.
• Implanted electronic devices.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Nursing, Physiotherapy and Podiatry Faculty

Seville, Spain, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Lourdes M Fernández Seguín, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lourdes M Fernández Seguín, PhD

CONTACT

630258773; lfdez@us.es

Cayetano Navarro Rico, Phd Student

CONTACT

664894442; cayetanonavarro95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor. Physiotherapy Department

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2024-05

Locations

ES (1)