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Completed

NCT Number: NCT01541020

Inspiratory Resistive Loading and Proprioceptive Postural Control

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 loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Proprioceptive Impairment Respiratory Loading Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

healthy individuals:

  • Age: 18-45 years old
  • No history of low back pain
  • A score of 0% 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

Treatment and study plan

Primary outcomes

  1. Proprioceptive postural control

    Time frame: 1 year

    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 outcomes

  1. Back muscle oxygenation

    Time frame: 1 year

    Near infrared spectroscopy: tissue oxygenation index (TOI) and haemoglobin

  2. Kinematics

    Time frame: 1 year

    piezoresistive accelerometers

  3. Respiratory muscle force

    Time frame: 1 year

    maximal inspiratory pressure - maximal expiratory pressure

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Inspiratory Resistive Loading and Proprioceptive Postural Control in Healthy Individuals and Individuals With Recurrent Low Back Pain

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 29, 2012
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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