Inspiratory Resistive Loading and Diaphragm Fatigue

NCT ID: NCT01505517

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diaphragm Fatigue Healthy Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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individuals with low back pain

No interventions assigned to this group

healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Simon Brumagne

Prof. dr. Simon Brumagne

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Brumagne, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Thierry Troosters, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.

Reference Type BACKGROUND
PMID: 20393397 (View on PubMed)

Hermans G, Agten A, Testelmans D, Decramer M, Gayan-Ramirez G. Increased duration of mechanical ventilation is associated with decreased diaphragmatic force: a prospective observational study. Crit Care. 2010;14(4):R127. doi: 10.1186/cc9094. Epub 2010 Jul 1.

Reference Type BACKGROUND
PMID: 20594319 (View on PubMed)

Other Identifiers

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1.5.104.03, G.0674.09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011_SBrumagne_DiaphFatigue

Identifier Type: -

Identifier Source: org_study_id