- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01753726
Diaphragm Stretching Increases Spine and Thoracic Mobility
October 30, 2016 updated by: Marie Carmen Valenza, Universidad de Granada
Diaphragm Stretching Technique Increases Spine Mobility and Thoracic Movement: a Randomized Controlled Trial
Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to spinal pathologies.
The aim of this study was to evaluate the effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spinal pain is a well recognized condition associated with significant personal and community burdens.
Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72% in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age.
During the last decades numerous researches have been conducted on stretching effects, evidencing an increased muscle control, flexibility and range of motion.
The main purpose of this investigation is to examine the effects of diaphragm stretching in spine and thoracic mobility in healthy subjects in order to apply the results in a specifics pathologies in future studies.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Granada, Spain, 18071
- Faculty of Health Sciences. University of Granada.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
- Age: between 18 and 65 years old.
Exclusion Criteria:
- Pathological subjects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
43 people are recruited in order to the inclusion criteria for the study.
They are healthy people.
A diaphragm stretching technique was employed in this experimental group.
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A manual technique of diaphragm stretching during 7 minutes.
The participants were situated in a seated position.
Other Names:
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Placebo Comparator: Placebo group
37 healthy people were recruited in order to the inclusion criteria.
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Disconnected ultrasound was used for the 7 min as sham treatment
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of lumbar mobility
Time Frame: up to 2 months
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Schober test is a flexion trunk test to evaluate lumbar spine mobility.
During this test, while the patient is in the standing position, marks are made in the midpoint between the posterior superior iliac spines (PSISs) and 10 cm superiorly to this point.
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up to 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of trunk mobility
Time Frame: baseline, 2 months
|
In Finger to floor test, the subjects were stood on a stool and asked to flex the trunk forward in order to reach as far as possible with both hands, without blending their knees.
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baseline, 2 months
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Cervical mobility
Time Frame: baseline, 2 months.
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A Baseline Bubble Inclinometer, Fabrication Enterprises Incorporated, New York.
USA, was used to measure de active range of motion of the cervical spine.
The measurements were performed in two planes of movement, lateral flexion (frontal plane) the right and left side; and flexion-extension (sagittal plane)
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baseline, 2 months.
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Abdominal and Thoracic Dimensions and Kinematics
Time Frame: baseline, 2 months.
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Abdominal and thoracic dimensions and kinematics measurements can be used as an evaluative method for diaphragmatic breathing excursion to quantify possible alterations in thoracic capacity and abdominal and chest wall compliance as achieved by all expiratory and inspiratory muscles
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baseline, 2 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Carmen Valenza, PH MD, Department of Physical Therapy. University of Granada.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 17, 2012
First Submitted That Met QC Criteria
December 19, 2012
First Posted (Estimate)
December 20, 2012
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 30, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- DF0037UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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