HealthyNCT03495843
The Influence Body Position and Axial Load on Spinal Stiffness
An observational study of Healthy, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Healthy
- What is being tested?
- Spinal stiffness
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 8 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Adult
Study population: Young healthy adults
Who may be able to join
- healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.
Read the 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.
- Conditions
- Healthy
- Being tested
- Spinal stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal stiffnessDiagnostic test
Spinal stiffness will be assessed with a device, which measures tissue compliance according to the concept of impulse-response
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day one of the study
Secondary outcomes (1)
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.
Measured: Day one of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Jul 2018
- Study completion8 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495843
- Sponsor's protocol ID
- 2017-01245
- Other IDs
- 2017
- Status last verified
- Jul 2018
- First submitted
- 5 Apr 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03495843
- Acronym / sponsor ID
- 2017-01245
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to examine the influence of body position and additional axial load on spinal stiffness in young healthy adults.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young healthy adults
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal stiffnessSpinal stiffness will be assessed with a device, which measures tissue compliance according to the concept of impulse-response | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Pain during measuring spinal stiffness
Time frame: Day one of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal stiffness (time frame: Day one of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.