NCT01505582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

January 4, 2012

Last Update Submit

December 10, 2013

Conditions

Inspiratory Muscle TrainingLow Back PainRespiratory Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL
Other: Inspiratory muscle training

Sham inspiratory muscle training

SHAM COMPARATOR
Other: Sham inspiratory muscle training

Interventions

Inspiratory muscle trainingOTHER

Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max

Also known as: Powerbreathe Classic
Inspiratory muscle training
Sham inspiratory muscle trainingOTHER

Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max

Also known as: Powerbreathe Classic
Sham inspiratory muscle training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 20393397BACKGROUND

MeSH Terms

Conditions

Low Back PainRespiration Disorders

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract Diseases

Study Officials

  • Simon Brumagne, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Thierry Troosters, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Roeland Lysens, MD, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Peter Van Wambeke, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Simon Brumagne

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 11, 2013

Record last verified: 2012-01

Locations

BE(1)