Effectiveness of Visceral Manual Therapy in Bruxist Patients

NCT ID: NCT05751694

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Visceral manual treatment

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

Group Type: EXPERIMENTAL

Visceral manual treatment

Intervention Type: 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.

Respiratory listening

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

Group Type: ACTIVE_COMPARATOR

Respiratory listening

Intervention Type: 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.

Interventions

Visceral manual treatment

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.

Intervention Type: PROCEDURE

Respiratory listening

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.
• Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
• Patients who have previous experience with manual treatment of the diaphragm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Lourdes María Fernández Seguín

Assistant Professor. Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lourdes M Fernández Seguín, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Nursing, Physiotherapy and Podiatry Faculty

Seville, Spain, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Lourdes M Fernández Seguín, PhD

Role: CONTACT

lfdez@us.es

630258773 ext. +34

Cayetano Navarro Rico, Phd Student

Role: CONTACT

cayetanonavarro95@gmail.com

664894442 ext. +34

Facility Contacts

Lourdes María Fernández-Seguín, PhD

Role: primary

Other Identifiers

070223TDCNR

Identifier Type: -

Identifier Source: org_study_id