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Completed

NCT Number: NCT01505517

Inspiratory Resistive Loading and Diaphragm Fatigue

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.

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Key information

Conditions

Diaphragm Fatigue Back Pain Healthy Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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