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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05197907
Other study ID # N43/DBS/000115
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 30, 2022

Study information

Verified date January 2022
Source Jagiellonian University
Contact Roksana S. Wójcik, MSc
Phone 12 634 33 97
Email roksanaa.wojcik@student.uj.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 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?


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Poland Jagiellonian University Medical College Cracovia

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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