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Inspiratory Resistive Loading and Diaphragm Fatigue

This study has been completed.
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01505517
First received: January 4, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Diaphragm Fatigue
Healthy
Low Back Pain

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • transdiaphragmatic pressure [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
individuals with low back pain
healthy controls

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 4, 2012
Last Updated: July 31, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Respiratory Aspiration
Back Pain
Fatigue
Low Back Pain
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013