Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
Primary Purpose
Shoulder Dislocation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Boss-Holzach-Matter method
Spaso method
Anti-Inflammatory Agents, Non-Steroidal
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Dislocation
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.
Sites / Locations
- Corporación sanitaria Parc Taulí de Sabadell
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Spaso Method
Boss-Holzach-Matter Method
Arm Description
Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02527603
Brief Title
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
Official Title
Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spaso Method
Arm Type
Experimental
Arm Description
Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Arm Title
Boss-Holzach-Matter Method
Arm Type
Experimental
Arm Description
Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
Intervention Type
Procedure
Intervention Name(s)
Boss-Holzach-Matter method
Other Intervention Name(s)
Self-assited Method
Intervention Description
The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced
Intervention Type
Procedure
Intervention Name(s)
Spaso method
Intervention Description
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
Drug
Intervention Name(s)
Anti-Inflammatory Agents, Non-Steroidal
Other Intervention Name(s)
Pain Killer, "Enantyum®"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Pain that the patient experiences during the reduction procedure
Description
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].
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Marti, PhD
Organizational Affiliation
Doctor
Official's Role
Study Director
Facility Information:
Facility Name
Corporación sanitaria Parc Taulí de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat
Learn more about this trial
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
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