Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

NCT ID: NCT02527603

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-31

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spaso Method

Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral

Group Type: EXPERIMENTAL

Spaso method

Intervention Type: PROCEDURE

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.

Anti-Inflammatory Agents, Non-Steroidal

Intervention Type: DRUG

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.

Boss-Holzach-Matter Method

Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral

Group Type: EXPERIMENTAL

Boss-Holzach-Matter method

Intervention Type: PROCEDURE

The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced

Anti-Inflammatory Agents, Non-Steroidal

Intervention Type: DRUG

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.

Interventions

Boss-Holzach-Matter method

The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Self-assited Method; Pain Killer, "Enantyum®"

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Francesc A. Marcano-Fernández

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Marti, PhD

Role: STUDY_DIRECTOR

Doctor

Locations

Corporación sanitaria Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

CSPTCOT201501

Identifier Type: -

Identifier Source: org_study_id