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Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia

Primary Purpose

Diaphragm; Relaxation, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Fascial release of diaphragm muscle.
Classic massage of the abdomen.
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diaphragm; Relaxation focused on measuring diaphragm, low back pain, deep tissue massage, diaphragm relaxation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age within 20-40 yrs,
  • BMI within normal range (18.5-24.9)
  • lack of abdominal obesity
  • lack of chronic musculoskeletal conditions
  • written, conscious consent

Exclusion Criteria:

  • former abdominal surgery
  • abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.),
  • pregnancy
  • fever,
  • tumors,
  • blood hypertension,
  • former surgery of respiratory system ,
  • condition after surgical procedures in the area of the spine,
  • the occurrence of pain in the spine in the 3 months preceding the research experiment,
  • lack of conscious consent

Sites / Locations

  • Jagiellonian University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diaphragm fascial release group.

Classic massage group

Arm Description

Ten minutes lasting fascial release techinques performed on diaphragm.

Ten minutes lasting classic massage performed on abdomen.

Outcomes

Primary Outcome Measures

Assessemnt of change in muscle tension of selected muscles of lumbar region
Assessment of muscle superficial electromyography will be performed with sEMG device NuTrac Alpha2E (NeuroTrac Ltd.) on the following muscles: multifidus, longissimus and iliocostalis.

Secondary Outcome Measures

Assessment of change of range of motion of the lumbar spine.
The range of motion of the lumbar spine will be performed with the digital inclinometer (Baseline)
Assessment of change in peak expiratory flow in one second (PEF1)
The peak expiratory flow in one second will be performed with PF100 peakflometer (Microlife).

Full Information

First Posted
December 27, 2021
Last Updated
January 14, 2022
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT05197907
Brief Title
Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia
Official Title
Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The diaphragm performs many functions that are vital to the body as a whole. Some of them are not related only to ventilation. The diaphragm is part of the myofascial system in the human body. Therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. in patients reporting pain in the lumbosacral spine. Considering the complex role of the diaphragm, it seems reasonable to investigate the influence of the mobilization of the diaphragm (aimed at reducing diaphragm tension) on the tension of the extensor muscles of the lumbar spine. The assumption of this reserach is to investigate the correlation between the tension of the fascia in the area of the diaphragm to the tension of the muscles in the area of the lumbar spine. The fascial connections between the diaphragm and the muscles in the lumbar spine presented above suggest that the manual therapy performed within the diaphragm can effectively prevent the occurrence of pain, and might be a supportive measure in the treatment of pain in the spine. The aim of the study is to investigate the corellation between the tension of the fascia within the diaphragm and the tension of the posterior superficial tape. Research questions: How does manual therapy in the area of the tendon attachments of the diaphragm affect the relaxation of the extensor muscles of the lumbar spine? How can the therapy conducted only within the diaphragm, without interfering with the structures surrounding the spine, reduce the tension of the extensor muscles of the lumbar spine and, consequently, increase the range of its mobility in all planes? How will the introduced therapy change the tidal volume of the lungs?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm; Relaxation, Low Back Pain
Keywords
diaphragm, low back pain, deep tissue massage, diaphragm relaxation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diaphragm fascial release group.
Arm Type
Experimental
Arm Description
Ten minutes lasting fascial release techinques performed on diaphragm.
Arm Title
Classic massage group
Arm Type
Placebo Comparator
Arm Description
Ten minutes lasting classic massage performed on abdomen.
Intervention Type
Procedure
Intervention Name(s)
Fascial release of diaphragm muscle.
Intervention Description
The intervention consists of deep tissue massage techniques and manual mobilization of the fascia performed within the diaphragm attachments in the area of the costal arches.
Intervention Type
Procedure
Intervention Name(s)
Classic massage of the abdomen.
Intervention Description
The intervention consists of selected classic massage techniques - mainly stroking (effleurage) - performed on the superficial layers of the abdominal region
Primary Outcome Measure Information:
Title
Assessemnt of change in muscle tension of selected muscles of lumbar region
Description
Assessment of muscle superficial electromyography will be performed with sEMG device NuTrac Alpha2E (NeuroTrac Ltd.) on the following muscles: multifidus, longissimus and iliocostalis.
Time Frame
Twice - before and immediately after the treatment procedure
Secondary Outcome Measure Information:
Title
Assessment of change of range of motion of the lumbar spine.
Description
The range of motion of the lumbar spine will be performed with the digital inclinometer (Baseline)
Time Frame
Twice - before and immediately after the treatment procedure
Title
Assessment of change in peak expiratory flow in one second (PEF1)
Description
The peak expiratory flow in one second will be performed with PF100 peakflometer (Microlife).
Time Frame
Twice - before and immediately after the treatment procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age within 20-40 yrs, BMI within normal range (18.5-24.9) lack of abdominal obesity lack of chronic musculoskeletal conditions written, conscious consent Exclusion Criteria: former abdominal surgery abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.), pregnancy fever, tumors, blood hypertension, former surgery of respiratory system , condition after surgical procedures in the area of the spine, the occurrence of pain in the spine in the 3 months preceding the research experiment, lack of conscious consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roksana S. Wójcik, MSc
Phone
12 634 33 97
Ext
+48
Email
roksanaa.wojcik@student.uj.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartosz Trybulec, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Study Chair
Facility Information:
Facility Name
Jagiellonian University Medical College
City
Cracovia
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roksana Wójcik, MSc
Phone
12 6343397
Ext
+48
Email
roksanaa.wojcik@student.uj.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia

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