Proprioceptive TrainingNCT01505595
Proprioceptive Training and Low Back Pain
A study testing Proprioceptive training in people with Proprioceptive Training and Low Back Pain, run by KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Proprioceptive Training, Low Back Pain
- What is being tested?
- Proprioceptive training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Proprioceptive Training, Low Back Pain
- Being tested
- Proprioceptive training, Sham proprioceptive training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
12 weeks
Sham proprioceptive trainingOther
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive training | Experimental | Not described Receives: Other: Proprioceptive training |
| Sham proprioceptive training | Sham comparator | Not described Receives: Other: Sham proprioceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Proprioceptive TrainingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Simon Brumagne, KU Leuven
- Investigators
- Simon Brumagne, PhD, Principal investigator, KU LeuvenThierry Troosters, PhD, Principal investigator, KU LeuvenRoeland Lysens, MD, PhD, Principal investigator, KU LeuvenPeter Van Wambeke, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505595
- Sponsor's protocol ID
- 2012_SBrumagne_PT-LBP
- Other IDs
- 1.5.104.03, G.0674.09
- Status last verified
- Feb 2019
- First submitted
- 4 Jan 2012
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20824281Johanson 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.
PubMed 21533851Janssens 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.
PubMed 20393397Brumagne 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.
PubMed 18594876Brumagne 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.
PubMed 18541428Janssens 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). 2016 Feb;32:40-8. doi: 10.1016/j.clinbiomech.2015.12.011. Epub 2016 Jan 6.
PubMed 26795132
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Training and Low Back Pain
- ClinicalTrials.gov ID
- NCT01505595
- Acronym / sponsor ID
- 2012_SBrumagne_PT-LBP
- Conditions
- Proprioceptive Training, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2012
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive training | Experimental | Other: Proprioceptive training |
| Sham proprioceptive training | Sham comparator | Other: Sham proprioceptive training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive training12 weeks | Other | Proprioceptive training |
| Sham proprioceptive trainingThree times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max | Other | Sham proprioceptive training |
Primary outcome
Proprioceptive postural control
Time frame: 12 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Background: PubMed 20824281Claeys 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.
- Background: PubMed 21533851Johanson 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.
- Background: PubMed 20393397Janssens 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.
- Background: PubMed 18594876Brumagne 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.
- Background: PubMed 18541428Brumagne 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.
- Derived from this study: PubMed 26795132Janssens 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). 2016 Feb;32:40-8. doi: 10.1016/j.clinbiomech.2015.12.011. Epub 2016 Jan 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Brumagne, PhD principal investigator
KU Leuven
Thierry Troosters, PhD principal investigator
KU Leuven
Roeland Lysens, MD, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive training in people with Proprioceptive Training and Low Back Pain, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprioceptive postural control (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505595, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.