- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541020
Inspiratory Resistive Loading and Proprioceptive Postural Control
Inspiratory Resistive Loading and Proprioceptive Postural Control in Healthy Individuals and Individuals With Recurrent Low Back Pain
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 loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Katholieke Universiteit Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Inclusion Criteria healthy individuals:
- Age: 18-45 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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Healthy individuals
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Individuals with low back pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proprioceptive postural control
Time Frame: 1 year
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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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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Back muscle oxygenation
Time Frame: 1 year
|
Near infrared spectroscopy: tissue oxygenation index (TOI) and haemoglobin
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1 year
|
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Kinematics
Time Frame: 1 year
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piezoresistive accelerometers
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1 year
|
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Respiratory muscle force
Time Frame: 1 year
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maximal inspiratory pressure - maximal expiratory pressure
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Brumagne, PhD, KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011_SBrumagne_HealthyLBP
- 1.5.104.03, G.0674.09 (Other Grant/Funding Number: Research Foundation Flanders (FWO))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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