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Inspiratory Muscle Training and Low Back Pain

This study is currently recruiting participants.
Verified January 2012 by Katholieke Universiteit Leuven
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01505582
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Inspiratory Muscle Training
Low Back Pain
Respiratory Disorders
 Other: Inspiratory muscle training
Other: Sham inspiratory muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Proprioceptive postural control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505582

Contacts
Contact: Lotte Janssens, PhD student 003216329082 lotte.janssens@faber.kuleuven.be
Contact: Simon Brumange, PhD 003216329121 simon.brumagne@faber.kuleuven.be

Locations
Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Lotte Janssens, PhD student     003216329082     lotte.janssens@faber.kuleuven.be    
Contact: Simon Brumagne, PhD     003216329121     simon.brumagne@faber.kuleuven.be    
Sub-Investigator: Lotte Janssens, PhD student            
Principal Investigator: Simon Brumagne, PhD            
Principal Investigator: Thierry Troosters, PhD            
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
  More Information

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
Study First Received: January 4, 2012
Last Updated: January 5, 2012
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013