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Inspiratory Muscle Training and Low Back Pain

NCT ID: NCT01505582

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inspiratory Muscle Training Low Back Pain Respiratory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inspiratory muscle training

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

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

Sham inspiratory muscle training

Group Type SHAM_COMPARATOR

Sham inspiratory muscle training

Intervention Type OTHER

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

Interventions

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Inspiratory muscle training

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

Intervention Type OTHER

Sham inspiratory muscle training

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

Intervention Type OTHER

Other Intervention Names

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Powerbreathe Classic Powerbreathe Classic

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Simon Brumagne

Prof. dr. Simon Brumagne

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Brumagne, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Thierry Troosters, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Roeland Lysens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Peter Van Wambeke, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 20393397 (View on PubMed)

Other Identifiers

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1.5.104.03, G.0674.09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012_SBrumagne_IMT-LBP

Identifier Type: -

Identifier Source: org_study_id