Inspiratory Muscle Training and Low Back Pain
Primary Purpose
Inspiratory Muscle Training, Low Back Pain, Respiratory Disorders
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Inspiratory muscle training
Sham inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Inspiratory Muscle Training
Eligibility 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
Sites / Locations
- Katholieke Universiteit Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Inspiratory muscle training
Sham inspiratory muscle training
Arm Description
Outcomes
Primary Outcome Measures
Proprioceptive postural control
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01505582
First Posted
January 4, 2012
Last Updated
December 10, 2013
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01505582
Brief Title
Inspiratory Muscle Training and Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspiratory Muscle Training, Low Back Pain, Respiratory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Title
Sham inspiratory muscle training
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
Powerbreathe Classic
Intervention Description
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max
Intervention Type
Other
Intervention Name(s)
Sham inspiratory muscle training
Other Intervention Name(s)
Powerbreathe Classic
Intervention Description
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
Primary Outcome Measure Information:
Title
Proprioceptive postural control
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Brumagne, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Troosters, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roeland Lysens, MD, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Van Wambeke, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
20393397
Citation
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.
Results Reference
background
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Inspiratory Muscle Training and Low Back Pain
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