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Deltoid Muscle Contribution to Shoulder Function

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ClinicalTrials.gov Identifier: NCT03881462
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief Summary:

There is only one study in the literature about the quantitative effect of M. deltoideus on the movement of the shoulder. Here, the author described a 35-80% loss of abduction power after selective blockade of the N. axillaris. Gerber, on the other hand, found a loss of abduction force of 73-86% after blockade of the suprascapular nerve. These results are partly contradictory, which is why the investigators think that further investigation is needed.

For many questions in the field of shoulder orthopedics, this knowledge would provide an important additional basis for therapeutical decision-making. For example, in the treatment of rotator cuff ruptures but also in the implantation of both inverse and anatomical shoulder prostheses. Also, statements about different outcome prognoses could be made more precisely.

Therefore, the investigators would like to perform muscle strength measurements of the deltoid muscle on 12 healthy volunteers on the dominant arm.

Abduction, flexion, external rotation and internal rotation Mm. Infraspinatus, Supraspinatus and Subscapularis are tested respectively.

The investigators plan to carry out the measurements three times before and after an-anaesthesiological nerve block of the axillary nerve thus inactivating the deltoid muscle (performed exclusively by an anesthesiologist specialized in regional anesthesia). The success of the nerve block is confirmed by needle electromyographies (EMG) by a neurologist specialized in electrophysiology. Using EMG neurogenic pathologies within the tested muscles are also ruled out.

In order to exclude relevant rotator cuff pathologies the investigators will perform shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.


Condition or disease Intervention/treatment Phase
Nerve Injury Nerve Palsy Procedure: Axillary nerve block for artificial deltoid muscle palsy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Deltoid Muscle Contribution to Shoulder Function - An Experimental Approach
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Axillary nerve block
Axillary nerve block is performed in standardized manner and muscle force is measured before and after the block.
Procedure: Axillary nerve block for artificial deltoid muscle palsy

Axillary nerve block block (AXNB):

The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel connected to a nerve stimulator with the setting 0.5 mA current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid.





Primary Outcome Measures :
  1. Muscle strength of the rotator cuff [ Time Frame: 6 hours ]
    Strength of abduction, flexion, external rotation and internal rotation in Mm. infraspinatus, supraspinatus and subscapularis respectively measured in Newton before and after blockade of the N. axillaris.


Secondary Outcome Measures :
  1. Geometric shoulder data [ Time Frame: 15 minutes ]
    Analysis of the geometric data of the X-ray images and correlation with the primary outcome.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • American Society of anesthesiologists (ASA) classification I - II, both sexes
  • ≥ 18 years old
  • < 65 years old
  • Written informed consent as documented by signature

Exclusion:

  • Severe coagulopathy or intake of anticoagulants
  • History of alcohol abuse or the intake of psychotropic drugs
  • Pregnancy
  • Infection at the injection site or a systemic infection
  • Fever of unknown origin
  • Motor or sensory abnormalities in the arm
  • Any neuromuscular disorders
  • significant arthritis or other shoulder joint problems
  • Any co-morbidity that interferes with this study (e.g., stroke, pace maker placement, severe ischemia, cardiac disease, etc.)
  • inability to provide informed consent or follow simple instructions during experiment
  • contraindications for peripheral regional anaesthesia or local an-esthetics used in the study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881462


Locations
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Switzerland
Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital

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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03881462     History of Changes
Other Study ID Numbers: ID 2019-00135
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balgrist University Hospital:
muscle function
rotator cuff