Changes in the Ulnar Tissues by Shear-wave Elastography
Changes in the Tension of the Flexor Carpi Ulnar Muscle With the Tensioning of the Ulnar Nerve by Shear-wave Elastography: a Pilot Study
1 other identifier
observational
39
1 country
1
Brief Summary
A single-center, observational, prospective, single cohort study with before-after design. Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 4, 2018
August 1, 2018
2 months
April 17, 2018
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
elastographic soft tissue tension (KPa)
Tension (KPa) in the nerve, muscle and ulnar tendon measured by elastography shear-wave before and after putting the ulnar nerve in tension
1 day
Interventions
Measurement by shear-wave elastography of the nerve, muscle and ulnar tendon before and after the tension of the ulnar nerve
Eligibility Criteria
Healthy volunteers recruited among the students of the Francisco de Vitoria University.
You may qualify if:
- Francisco de Vitoria University student.
- Age between 18 and 26 years old.
You may not qualify if:
- History of neuropathies in upper limbs.
- Slight neck pain in the last 6 months of traumatic origin.
- Neck pain in the last 3 months.
- episodes of moderate / severe neck pain in the last year.
- History of fracture or dislocation in the upper extremity.
- Surgical history in the upper extremity.
- Cervical symptomatology or upper limb at the present time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guadarrama Hospitallead
- Universidad Francisco de Vitoriacollaborator
Study Sites (1)
J.Nicolas Cuenca Zaldivar
Guadarrama, Madrid, 28440, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
J. Nicolas Cuenca Zaldivar
Guadarrama Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehabilitation Service Principal Investigator
Study Record Dates
First Submitted
April 17, 2018
First Posted
April 26, 2018
Study Start
May 1, 2018
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ANALYTIC CODE
- Time Frame
- The data will be available permanently once the statistical analysis is complete.
- Access Criteria
- The data will be available freely and publicly.
The statistical analysis plan and the analytical code will be available in .html and .rmd format as well as the file with the raw data.