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The Influence Body Position and Axial Load on Spinal Stiffness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495843
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Swanenburg, Balgrist University Hospital

Brief Summary:
The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.

Condition or disease Intervention/treatment
Healthy Diagnostic Test: Spinal stiffness

Detailed Description:
Spinal stiffness plays an important role in the assessment of the spine in the clinical daily routine. It is often performed as a manual PA-pressure test in the prone position. The spinal stiffness is the result of the resistance from the active, passive and neurological subsystems, like muscles (active), ligaments, joint capsule and the skin (passive). Further research had shown, that the spinal stiffness depends also from other factors. It is increased by axial compression. A better understanding of spinal stiffness leads to novel insights into spinal stabilization mechanisms.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing Normative Data, Reliability and the Influence of Body Position and Axial Load on Spinal Stiffness by Electromechanical Measurements in Young Healthy Adults
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 8, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Spinal stiffness
    Spinal stiffness will be assessed with a device, which measures tissue compliance according to the concept of impulse-response


Primary Outcome Measures :
  1. Spinal stiffness [ Time Frame: Day one of the study ]

    posterior-to-anterior spinal will be assesd in prone and upright body position and in upright body position with additional axial.

    The device measures tissue compliance according to the concept of impulse-response. A force of exact 80 Newton will be applied from the device to the process spinous. The expected impulse-response (result) will be between 40 Newton and 70 Newton.



Secondary Outcome Measures :
  1. Pain during measuring spinal stiffness [ Time Frame: Day one of the study ]
    Visual Analogue Pain Rating Scale will be used if the particepants feel any pain during the measurement.The participant will be asked to rate his pain intensity on a straight line (100 millimeter) with two endpoints.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Young healthy adults
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • Acute backpain (thoracal or lumbar)
  • History of significant backpain (thoracal or lumbar) or radiating pain down the leg
  • Contraindications to PA mobilisation/manipulation
  • Spinal fractures
  • Spinal tumors
  • Surgical intervention in the thoracic and lumbar spine
  • Local infections of the spine or the surrounding tissue

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495843


Locations
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Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Principal Investigator: Jaap Swanenburg, PhD Balgrist University Hospital
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Responsible Party: Swanenburg, PhD, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03495843    
Other Study ID Numbers: 2017-01245
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No