NCT05197907

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:

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

December 27, 2021

Last Update Submit

January 14, 2022

Conditions

Keywords

diaphragmlow back paindeep tissue massagediaphragm relaxation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of change of range of motion of the lumbar spine.

    Twice - before and immediately after the treatment procedure

  • Assessment of change in peak expiratory flow in one second (PEF1)

    Twice - before and immediately after the treatment procedure

Study Arms (2)

Diaphragm fascial release group.

EXPERIMENTAL

Ten minutes lasting fascial release techinques performed on diaphragm.

Procedure: Fascial release of diaphragm muscle.

Classic massage group

PLACEBO COMPARATOR

Ten minutes lasting classic massage performed on abdomen.

Procedure: Classic massage of the abdomen.

Interventions

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.

Diaphragm fascial release group.

The intervention consists of selected classic massage techniques - mainly stroking (effleurage) - performed on the superficial layers of the abdominal region

Classic massage group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Medical College

Krakow, Poland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bartosz Trybulec, PhD

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

Roksana S. Wójcik, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 20, 2022

Study Start

August 1, 2021

Primary Completion

March 31, 2022

Study Completion

July 30, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations