Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects.

Efficacy of the Transverse Planes Technique in the Diaphragmatic Region in Young Subjects. A Randomized Controlled Trial

In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Diaphragm Issues
• Intervention / Treatment: Other: manipulation

Detailed Description

The intervention will be carried out for 4 weeks, with 1 weekly session of 10 minutes duration. The patient will go to the intervention room where the treatment procedure will be explained in detail. He will be explained verbally and with a visual demonstration of what the technique consists of and how it is going to be performed, the position that he has to adopt during and how long the intervention will last.

The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.

The patient will be asked to focus on their own breathing and the contact that the therapist will apply.

In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy people
• no spinal pathology
• no respiratory pathology

Exclusion Criteria:

• have suffered spinal pathologies in the last 3 months
• have suffered respiratory diseases in the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.	Other: manipulation; miofascial technique in diaphragmatic region
Sham Comparator: Control group; In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.	Other: manipulation; miofascial technique in diaphragmatic region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centimetric measurement of the thorax	measuring the difference in circumference after maximum inhalation through the nose and maximum exhalation through the mouth, the measurement is made at the level of the xiphoid process	change from baseline to one month
Back range of motion	Performing the Ott Test, which consists of performing, with the subject standing, two measurements, one in the lower part of the spinous process of C7 and the other 30 centimeters below the previous mark.	change from baseline to one month
Inspiratory and expiratory capacity	will be carried out using an incentive spirometer	change from baseline to one month

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CE022305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No