Healthy Clinical Trial
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
| 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 |
| Verified date | July 2018 |
| Source | Balgrist University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Balgrist University Hospital | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Balgrist University Hospital |
Switzerland,
| 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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