The Influence Body Position and Axial Load on Spinal Stiffness

Assessing Normative Data, Reliability and the Influence of Body Position and Axial Load on Spinal Stiffness by Electromechanical Measurements in Young Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young healthy adults

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal stiffness	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.	Day one of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during measuring spinal stiffness	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.	Day one of the study

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Jaap Swanenburg, PhD, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 8, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2017-01245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No