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The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility

Primary Purpose

Fascia; Inflammation, Thoracic, Rotation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Measuring thoracic rotation mobility
Sponsored by
International Academy of Osteopathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fascia; Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects between the age of 18 and 65
  • Both men and women

Exclusion Criteria:

  • Structural disease of cervical or/and thoracic spine and/or head and/or thorax
  • Acute mobility restriction of cervical and/or thoracic spine
  • Acute and/or intense pain
  • A history of trauma and/or operation on cervical and/or thoracic spine
  • Treatment for cancer like chemo or radiation
  • Baby's and children
  • Elderly people

Sites / Locations

  • Practice for fysiotherapy and osteopathy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stretching of intrathoracic fascia

Test without stretching

Arm Description

A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.

A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.

Outcomes

Primary Outcome Measures

Change in thoracic rotation mobility
Change from baseline rotation, left and right, to rotation immediately after the test

Secondary Outcome Measures

Full Information

First Posted
April 22, 2020
Last Updated
May 27, 2020
Sponsor
International Academy of Osteopathy
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1. Study Identification

Unique Protocol Identification Number
NCT04411095
Brief Title
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Official Title
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Academy of Osteopathy

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
Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.
Detailed Description
Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility. Subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility. Data will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fascia; Inflammation, Thoracic, Rotation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching of intrathoracic fascia
Arm Type
Experimental
Arm Description
A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.
Arm Title
Test without stretching
Arm Type
Placebo Comparator
Arm Description
A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.
Intervention Type
Other
Intervention Name(s)
Measuring thoracic rotation mobility
Intervention Description
Measuring the thoracic rotation mobility with a goniometer, from a standardized position
Primary Outcome Measure Information:
Title
Change in thoracic rotation mobility
Description
Change from baseline rotation, left and right, to rotation immediately after the test
Time Frame
Before and immediately after the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects between the age of 18 and 65 Both men and women Exclusion Criteria: Structural disease of cervical or/and thoracic spine and/or head and/or thorax Acute mobility restriction of cervical and/or thoracic spine Acute and/or intense pain A history of trauma and/or operation on cervical and/or thoracic spine Treatment for cancer like chemo or radiation Baby's and children Elderly people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IAO Administration
Organizational Affiliation
The International Academy of Osteopathy
Official's Role
Study Director
Facility Information:
Facility Name
Practice for fysiotherapy and osteopathy
City
Scherpenheuvel
State/Province
Vlaams-brabant
ZIP/Postal Code
3270
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility

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