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Inspiratory Resistive Loading and Diaphragm Fatigue

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ClinicalTrials.gov Identifier: NCT01505517
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven

Brief Summary:
The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.

Condition or disease
Diaphragm Fatigue Healthy Low Back Pain

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Fatigue
U.S. FDA Resources

Group/Cohort
individuals with low back pain
healthy controls



Primary Outcome Measures :
  1. transdiaphragmatic pressure [ Time Frame: 18 months ]
    transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
young flemish volunteers
Criteria

Inclusion Criteria individuals with low back pain:

  • Age: 18-35 years old
  • At least 1 year of low back pain with/without referred pain in buttock/thigh
  • At least 3 episodes of disabling low back pain
  • At least a score of 20% on the Oswestry Disability Index
  • Willingness to sign the informed consent

Inclusion Criteria healthy individuals:

  • Age: 18-35 years old
  • No history of low back pain
  • A score of 0% on the Oswestry Disability Index
  • Willingness to sign the informed consent

Exclusion Criteria:

  • History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
  • One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
  • Radicular symptoms
  • Not Dutch-speaking
  • Strong opioids
  • Neck pain
  • Smoking history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505517


Locations
Belgium
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Simon Brumagne, PhD Katholieke Universiteit Leuven
Principal Investigator: Thierry Troosters, PhD Katholieke Universiteit Leuven

Publications:
Responsible Party: Simon Brumagne, Prof. dr. Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01505517     History of Changes
Other Study ID Numbers: 2011_SBrumagne_DiaphFatigue
1.5.104.03, G.0674.09 ( Other Grant/Funding Number: Research Foundation Flanders (FWO) )
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: July 2012

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Fatigue
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms