Inspiratory Resistive Loading and Diaphragm Fatigue

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505517
• Other study ID #: 2011_SBrumagne_DiaphFatigue
• Secondary ID: 1.5.104.03, G.06
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: December 4, 2013
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Back Pain
• Diaphragm Fatigue
• Fatigue
• Healthy
• Low Back Pain

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transdiaphragmatic pressure	transdiaphragmatic pressure measurement in response to bilateral anterior magnetic phrenic nerve stimulation before and after an inspiratory resistive loading protocol	18 months	Yes