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Proprioceptive Training and Low Back Pain

Primary Purpose

Proprioceptive Training, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Proprioceptive training
Sham proprioceptive training
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proprioceptive Training

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Proprioceptive training

Sham proprioceptive 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

First Posted
January 4, 2012
Last Updated
February 7, 2019
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01505595
Brief Title
Proprioceptive Training and Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proprioceptive Training, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive training
Arm Type
Experimental
Arm Title
Sham proprioceptive training
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Proprioceptive training
Intervention Description
12 weeks
Intervention Type
Other
Intervention Name(s)
Sham proprioceptive training
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
12 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
20824281
Citation
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.
Results Reference
background
PubMed Identifier
21533851
Citation
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.
Results Reference
background
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
PubMed Identifier
18594876
Citation
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.
Results Reference
background
PubMed Identifier
18541428
Citation
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.
Results Reference
background
PubMed Identifier
26795132
Citation
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.
Results Reference
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Proprioceptive Training and Low Back Pain

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