Research with human participants

Overview of medical research in the Netherlands

Biomechanical Reposition techniques in Anterior Shoulder Dislocation.

Biomechanische repositie technieken van een schouder ontwrichting

No registrations found.

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Ethical review
Not applicable
Status
Pending
Health condition type
-
Study type
Interventional

ID

NL-OMON20640

Source

NTR

Brief title

BRASD-trial

Health condition

Shoulder dislocation, anterior (confirmed by lateral and AP X-ray)

Schouderontwrichting (anterior) (radiologisch bevestigd)

Sponsors and support

Primary sponsor :
Flevoziekenhuis
Hospitaalweg 1, 1315 RA Almere
The Netherlands
+31 (0) 36 - 868 88 88
Source(s) of monetary or material Support :
No funding source applicable

Intervention

Outcome measures

Primary outcome

Primary outcome length of ED stay will be described in minutes and will be analysed using ANOVA analyse in case of normality can be assumed, or Kruskall-Wallis test in case of normality cannot be assumed. Median/average pain on the NRS scale during and after reposition will be also be analysed using ANOVA analyse in case of normality can be assumed, or Kruskall-Wallis test in case of normality cannot be assumed.

Secondary outcome

Secondary outcome will be procedure time in minutes, percentage of successful reduction, complications, patients satisfaction and analgesia/sedation used, These secondary outcomes will be reported individually and clustered.

Study objective

To establish which BRT or combination of BRTs is the fastest, least painful and has the lowest complication rate for adult patients with an anterior shoulder dislocation presenting in the emergency department (ED).

Study design

None

Intervention

Depending on ability to adduct patients will be randomized for biomechanical repositioning (BRT) according to Cunningham, Modified Milch or Scapular manipulation technique and Modified Milch or Scapula manipulation technique.

Public
Flevoziekenhuis - emergency deparment

M. Roetman
Hospitaalweg 1

Almere 1315 RA
The Netherlands
+31 (0)36 8688811
mroetman@flevoziekenhuis.nl
Scientific
Flevoziekenhuis - emergency deparment

M. Roetman
Hospitaalweg 1

Almere 1315 RA
The Netherlands
+31 (0)36 8688811
mroetman@flevoziekenhuis.nl

Inclusion criteria

All adult patients (> 18 years) with an isolated anterior shoulder dislocation

Exclusion criteria

• subcapital humeral fractures

• multi trauma

• subclavicul-, thoracic- , inferior or posterior
dislocation

• dislocations presented after 24 hours

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
222
Type :
Anticipated

Not applicable
Application type :
Not applicable

Followed up by the following (possibly more current) registration

ID: 47421
Bron: ToetsingOnline
Titel: BRASD: Biomechanical Reposition techniques in Anterior Shoulder Dislocation. A randomised multicenter clinical trial.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5600
NTR-old NTR5839
CCMO NL54173.094.15
OMON NL-OMON47421