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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495843
Other study ID # 2017-01245
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date July 8, 2018

Study information

Verified date July 2018
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 8, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Balgrist University Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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