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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23100318
Publication citations
-
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.