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Inspiratory Muscle Training and Low Back Pain

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ClinicalTrials.gov Identifier: NCT01505582
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven

Brief Summary:

Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.

The aim of the study is to clarify whether inspiratory muscle training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.


Condition or disease Intervention/treatment Phase
Inspiratory Muscle Training Low Back Pain Respiratory Disorders Other: Inspiratory muscle training Other: Sham inspiratory muscle training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Inspiratory muscle training Other: Inspiratory muscle training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max
Other Name: Powerbreathe Classic
Sham Comparator: Sham inspiratory muscle training Other: Sham inspiratory muscle training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
Other Name: Powerbreathe Classic



Primary Outcome Measures :
  1. Proprioceptive postural control [ Time Frame: 8 weeks ]
    Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria individuals with low back pain:

  • Age: 18-45 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

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): NCT01505582


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
Principal Investigator: Roeland Lysens, MD, PhD Katholieke Universiteit Leuven
Principal Investigator: Peter Van Wambeke, MD Universitaire Ziekenhuizen Leuven

Publications:
Responsible Party: Simon Brumagne, Prof. dr. Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01505582     History of Changes
Other Study ID Numbers: 2012_SBrumagne_IMT-LBP
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 11, 2013
Last Verified: January 2012

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