Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Spaso method; Drug: Anti-Inflammatory Agents, Non-Steroidal; Procedure: Boss-Holzach-Matter method

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporación sanitaria Parc Taulí de Sabadell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Study Director: David Marti, PhD, Doctor

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 15, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: CSPTCOT201501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat