An interventional study of Boss-Holzach-Matter method and Spaso method in Shoulder Dislocation, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment
To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.
Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.
Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.
Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.
Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.
190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.
This study's enrollment of 60 is above the median of 53 across 120 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Procedure: Spaso method · Drug: Anti-Inflammatory Agents, Non-Steroidal
Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Procedure: Boss-Holzach-Matter method · Drug: Anti-Inflammatory Agents, Non-Steroidal
The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced
Also known as: Self-assited Method
The physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished.
All patients will be administered a dose of NSAI intra-muscular or orally ("Dexketoprofen", "Enantyum®") it is part of the normal treatment of these patients to cope with pain.
Also known as: Pain Killer, "Enantyum®"
Change From Baseline in Pain that the patient experiences during the reduction procedure
Pain the patient feels during the reduction maneuver. The patient will be asked after reduction to fill out a form with a analog visual scale with scores ranging from 0 \[no pain\] to 10 \[worst possible pain\].
Time frame: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.
Plan to share: Undecided — Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Corporacion Parc Tauli