Condition category
Signs and Symptoms
Date applied
22/05/2009
Date assigned
15/07/2009
Last edited
29/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Josephine Yuen Man Chung

ORCID ID

Contact details

Flat C
2/F
Block 22
Phase 3
Classical Gardens
Tai Po
Hong Kong
-
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRE-2008.326-T

Study information

Scientific title

The effectiveness of a specially designed shoulder chair for closed reduction of acute shoulder dislocation in the emergency department: a prospective, unblinded randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to demonstrate the effectiveness of the new reduction method by measuring:
1. Length of patient accident and emergency (A & E) stay
2. Length of the procedure
3. Successful reduction rate
4. Levels of pain experienced by patients in different time periods before and after the reduction

Ethics approval

The Joint Chinese University of Hong Kong (CUHK) and New Territories East Cluster (NTEC) Clinical Research Ethics Committee gave approval on the 13th October 2008 (ref: CRE-2008.326-T)

Study design

Prospective unblinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute shoulder dislocation

Intervention

Subjects will be randomly assigned into two study groups. In the normal practice group, the Kocher's manoeuvre will be suggested as a primary reduction technique. Emergency physicians can also use any recognised method for closed reduction according to their preferences and clinical judgment. Physicians should follow the pre-established study analgesic and sedation pathway to give medication. In the shoulder chair group, shoulder reduction will be performed by emergency physicians or emergency nurse practitioners.

Oral medication:
In both groups, oral paracetamol 1 g will be used.

Intravenous medication:
Both groups can have rescue analgesia - intravenous morphine 2 mg (increments as required) if patient requests.

In addition, for the normal practice group, intravenous 2 mg of midazolam will be used before conducting the reduction. Physicians can titrate 1 mg every 2 - 3 minutes to improve conditions to allow a satisfactory level of sedation for reduction.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Length of patient stay in the ED, measured one and half years after the study commenced.

Secondary outcome measures

1. Length of the procedure
2. Successful reduction rate
3. Levels of pain experienced by patients in different time periods before and after the reduction

Measured one and half years after the study commenced.

Overall trial start date

01/07/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Sample criteria are non-exclusive to gender and ethnic background. The sample inclusion criteria consists of:
1. Aged greater than or equal to 18 years
2. Anterior or posterior shoulder dislocation without fracture of the surgical neck of humerus
3. Patient who is able to communicate and cooperate
4. Height 150 cm or above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients in each of two groups (total = 60)

Participant exclusion criteria

1. Acute psychiatric disease
2. Inability to complete assessment of pain, e.g. dementia
3. Contraindications to any study medication

Recruitment start date

01/07/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Flat C, 2/F, Block 22, Phase 3
Hong Kong
-
China

Sponsor information

Organisation

The Hong Kong College of Emergency Medicine (China)

Sponsor details

Room 809 HKAM Jockey Club Building
99 Wong Chuk Hang Road
Aberdeen
Hong Kong
-
China

Sponsor type

University/education

Website

http://www.hkam.org.hk/colleges/em.htm

Funders

Funder type

University/education

Funder name

The Hong Kong College of Emergency Medicine (China) - Research Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23100318

Publication citations

  1. Results

    Chung JY, Cheng CH, Graham CA, Rainer TH, The effectiveness of a specially designed shoulder chair for closed reduction of acute shoulder dislocation in the emergency department: a randomised control trial., Emerg Med J, 2013, 30, 10, 795-800, doi: 10.1136/emermed-2011-201011.

Additional files

Editorial Notes