Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527603
• Other study ID #: CSPTCOT201501
• Status: Completed
• Phase: N/A
• First received: August 15, 2015
• Last updated: March 20, 2017
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dislocations
• Shoulder Dislocation

Intervention

Procedure:
• Boss-Holzach-Matter method
The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced
• Spaso 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.

Drug:
• Anti-Inflammatory Agents, Non-Steroidal
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.

Locations

Country	Name	City	State
Spain	Corporación sanitaria Parc Taulí de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.