The effectiveness of a specially designed shoulder chair for closed reduction of acute shoulder dislocation in the emergency department
| ISRCTN | ISRCTN49254586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49254586 |
| Secondary identifying numbers | CRE-2008.326-T |
- Submission date
- 22/05/2009
- Registration date
- 15/07/2009
- Last edited
- 29/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Josephine Yuen Man Chung
Scientific
Scientific
Flat C, 2/F, Block 22, Phase 3
Classical Gardens
Tai Po
Hong Kong
-
China
Study information
| Study design | Prospective unblinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2009 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 patients in each of two groups (total = 60) |
| Key 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 |
| Key exclusion criteria | 1. Acute psychiatric disease 2. Inability to complete assessment of pain, e.g. dementia 3. Contraindications to any study medication |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- China
- Hong Kong
Study participating centre
Flat C, 2/F, Block 22, Phase 3
Hong Kong
-
China
-
China
Sponsor information
The Hong Kong College of Emergency Medicine (China)
University/education
University/education
Room 809 HKAM Jockey Club Building
99 Wong Chuk Hang Road
Aberdeen
Hong Kong
-
China
| Website | http://www.hkam.org.hk/colleges/em.htm |
|---|
Funders
Funder type
University/education
The Hong Kong College of Emergency Medicine (China) - Research Grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
