Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation

NCT02527603 | Completed DMC

• 1 other identifier: CSPTCOT201501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Spaso Method

EXPERIMENTAL

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

Procedure: Spaso method; Drug: Anti-Inflammatory Agents, Non-Steroidal

Boss-Holzach-Matter Method

EXPERIMENTAL

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

Procedure: Boss-Holzach-Matter method; Drug: Anti-Inflammatory Agents, Non-Steroidal

Interventions

Boss-Holzach-Matter method PROCEDURE

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

Also known as: Self-assited Method

Boss-Holzach-Matter Method

Spaso method 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.

Spaso Method

Anti-Inflammatory Agents, Non-Steroidal 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.

Also known as: Pain Killer, "Enantyum®"

Boss-Holzach-Matter Method; Spaso Method

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.

You may not qualify if:

• Fracture luxation of the same shoulder.
• Inability to cooperate due to mental or physical condition.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporación sanitaria Parc Taulí de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Anti-Inflammatory Agents, Non-Steroidal; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• David Marti, PhD

  Doctor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 15, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

ES (1)