Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

Not Applicable

Completed

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Spaso method; Procedure: Boss-Holzach-Matter method; Drug: Anti-Inflammatory Agents, Non-Steroidal

• Registration Number: NCT02527603
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-15
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spaso Method	Anti-Inflammatory Agents, Non-Steroidal	Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Boss-Holzach-Matter Method	Anti-Inflammatory Agents, Non-Steroidal	Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Spaso Method	Spaso method	Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Boss-Holzach-Matter Method	Boss-Holzach-Matter method	Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain that the patient experiences during the reduction procedure	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.	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 \[worst possible pain\].

Trial Locations

Locations (1)

Corporación sanitaria Parc Taulí de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain