Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Procedure: Boss-Holzach-Matter method
* Procedure: Spaso method
* Drug: Anti-Inflammatory Agents, Non-Steroidal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area. Exclusion Criteria: Fracture luxation of the same shoulder. Inability to cooperate due to mental or physical condition.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spaso Method<br>Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral | Procedure: Spaso method<br>* 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.<br>Drug: Anti-Inflammatory Agents, Non-Steroidal<br>* 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.<br>* Other names: Pain Killer, Enantyum®;|
| Experimental: Boss-Holzach-Matter Method<br>Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral | Procedure: Boss-Holzach-Matter method<br>* The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced<br>* Other names: Self-assited Method;Drug: Anti-Inflammatory Agents, Non-Steroidal<br>* 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.<br>* Other names: Pain Killer, Enantyum®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | 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. |