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Inspiratory Muscle Training and Low Back Pain

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01505582
Collaborator
Universitaire Ziekenhuizen Leuven (Other)
28
Enrollment
1
Location
2
Arms
23
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Inspiratory muscle training
  • Other: Sham inspiratory muscle training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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 Names:
  • 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 Names:
  • Powerbreathe Classic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proprioceptive postural control [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Katholieke Universiteit Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • KU Leuven
    • Universitaire Ziekenhuizen Leuven

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Simon Brumagne, Prof. dr. Simon Brumagne, KU Leuven
    ClinicalTrials.gov Identifier:
    NCT01505582
    Other Study ID Numbers:
    • 2012_SBrumagne_IMT-LBP
    • 1.5.104.03, G.0674.09
    First Posted:
    Jan 6, 2012
    Last Update Posted:
    Dec 11, 2013
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Respiration Disorders
    Respiratory Tract Diseases
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Dec 11, 2013