Diaphragm Stretching Increases Spine and Thoracic Mobility

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01753726
First received: December 17, 2012
Last updated: December 9, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Healthy
Other: Diaphragm stretching.
Other: Placebo.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diaphragm Stretching Technique Increases Spine Mobility and Thoracic Movement: a Randomized Controlled Trial

Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Assessment of lumbar mobility [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Assessment of trunk mobility [ Time Frame: baseline, 2 months ] [ Designated as safety issue: Yes ]
    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.

  • Cervical mobility [ Time Frame: baseline, 2 months. ] [ Designated as safety issue: Yes ]
    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)

  • Abdominal and Thoracic Dimensions and Kinematics [ Time Frame: baseline, 2 months. ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Diaphragm stretching.
A manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position.
Other Name: Manual technique
Placebo Comparator: Placebo group
37 healthy people were recruited in order to the inclusion criteria.
Other: Placebo.
Disconnected ultrasound was used for the 7 min as sham treatment
Other Name: Placebo

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Age: between 18 and 65 years old.

Exclusion Criteria:

  • Pathological subjects
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753726

Contacts
Contact: Marie Carmen Valenza, FT 958 248035 cvalenza@ugr.es
Contact: Marie Carmen Valenza, PhD 958 48035 cvalenza@ugr.es

Locations
Spain
Faculty of Health Sciences. University of Granada. Recruiting
Granada, Spain, 18071
Contact: M. Carmen , Ph, MD    958 248035      
Principal Investigator: M. Carmen Valenza, Ph, MD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: M. Carmen Valenza, PH MD Department of Physical Therapy. University of Granada.
  More Information

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01753726     History of Changes
Other Study ID Numbers: DF0037UG 
Study First Received: December 17, 2012
Last Updated: December 9, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
stretching, diaphragm, spinal movement, thoracic movement

ClinicalTrials.gov processed this record on August 22, 2016