Deltoid Muscle Contribution to Shoulder Function
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
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
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJanuary 14, 2020
August 1, 2019
3 months
February 15, 2019
January 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle strength of the rotator cuff
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.
6 hours
Secondary Outcomes (1)
Geometric shoulder data
15 minutes
Study Arms (1)
Axillary nerve block
EXPERIMENTALAxillary nerve block is performed in standardized manner and muscle force is measured before and after the block.
Interventions
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.
Eligibility Criteria
You may qualify if:
- American Society of anesthesiologists (ASA) classification I - II, both sexes
- ≥ 18 years old
- \< 65 years old
- Written informed consent as documented by signature
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Balgrist University Hospital
Zurich, 8008, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
March 19, 2019
Study Start
May 1, 2019
Primary Completion
July 30, 2019
Study Completion
September 30, 2019
Last Updated
January 14, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share