- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505595
Proprioceptive Training and Low Back Pain
February 7, 2019 updated by: Simon Brumagne, KU Leuven
Proprioceptive weighting changes may explain differences in postural control performance. Deficits in proprioception are found in a subgroup of patients with low back pain.
The aim of the study is to clarify whether proprioceptive training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium, 3000
- Katholieke Universiteit Leuven
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proprioceptive training
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12 weeks
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Sham Comparator: Sham proprioceptive training
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Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proprioceptive postural control
Time Frame: 12 weeks
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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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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Brumagne, PhD, KU Leuven
- Principal Investigator: Roeland Lysens, MD, PhD, KU Leuven
- Principal Investigator: Peter Van Wambeke, MD, Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.
- Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.
- Brumagne S, Janssens L, Janssens E, Goddyn L. Altered postural control in anticipation of postural instability in persons with recurrent low back pain. Gait Posture. 2008 Nov;28(4):657-62. doi: 10.1016/j.gaitpost.2008.04.015. Epub 2008 Jun 9.
- 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.
- Johanson E, Brumagne S, Janssens L, Pijnenburg M, Claeys K, Paasuke M. The effect of acute back muscle fatigue on postural control strategy in people with and without recurrent low back pain. Eur Spine J. 2011 Dec;20(12):2152-9. doi: 10.1007/s00586-011-1825-3. Epub 2011 May 1.
- Janssens L, Brumagne S, Claeys K, Pijnenburg M, Goossens N, Rummens S, Depreitere B. Proprioceptive use and sit-to-stand-to-sit after lumbar microdiscectomy: The effect of surgical approach and early physiotherapy. Clin Biomech (Bristol, Avon). 2016 Feb;32:40-8. doi: 10.1016/j.clinbiomech.2015.12.011. Epub 2016 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 5, 2012
First Posted (Estimate)
January 6, 2012
Study Record Updates
Last Update Posted (Actual)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_SBrumagne_PT-LBP
- 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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