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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, KU Leuven

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01505582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inspiratory Muscle Training and Low Back Pain
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Inspiratory Muscle Training
  • Low Back Pain
  • Respiratory Disorders
Intervention  ICMJE
  • Other: Inspiratory muscle training
    Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max
    Other Name: Powerbreathe Classic
  • Other: Sham inspiratory muscle training
    Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
    Other Name: Powerbreathe Classic
Study Arms  ICMJE
  • Experimental: Inspiratory muscle training
    Intervention: Other: Inspiratory muscle training
  • Sham Comparator: Sham inspiratory muscle training
    Intervention: Other: Sham inspiratory muscle training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
28
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
40
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505582
Other Study ID Numbers  ICMJE 2012_SBrumagne_IMT-LBP
1.5.104.03, G.0674.09 ( Other Grant/Funding Number: Research Foundation Flanders (FWO) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Simon Brumagne, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Universitaire Ziekenhuizen Leuven
Investigators  ICMJE
Principal Investigator: Simon Brumagne, PhD KU Leuven
Principal Investigator: Thierry Troosters, PhD KU Leuven
Principal Investigator: Roeland Lysens, MD, PhD KU Leuven
Principal Investigator: Peter Van Wambeke, MD Universitaire Ziekenhuizen Leuven
PRS Account KU Leuven
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP