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

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:

1. 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?
2. 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?
3. How will the introduced therapy change the tidal volume of the lungs?

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Diaphragm; Relaxation
• Intervention / Treatment: Procedure: Fascial release of diaphragm muscle.; Procedure: Classic massage of the abdomen.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roksana S. Wójcik, MSc; Phone Number: +48 12 634 33 97; Email: roksanaa.wojcik@student.uj.edu.pl

Study Locations

• Poland
  • Cracovia, Poland
    • Recruiting
    • Jagiellonian University Medical College
    • Contact: Roksana Wójcik, MSc; Phone Number: +48 12 6343397; Email: roksanaa.wojcik@student.uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diaphragm fascial release group.; Ten minutes lasting fascial release techinques performed on diaphragm.	Procedure: Fascial release of diaphragm muscle.; 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.
Placebo Comparator: Classic massage group; Ten minutes lasting classic massage performed on abdomen.	Procedure: Classic massage of the abdomen.; The intervention consists of selected classic massage techniques - mainly stroking (effleurage) - performed on the superficial layers of the abdominal region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Twice - before and immediately after the treatment procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Twice - before and immediately after the treatment procedure
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).	Twice - before and immediately after the treatment procedure

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Bartosz Trybulec, PhD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: low back pain; diaphragm; deep tissue massage; diaphragm relaxation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: N43/DBS/000115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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