Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326794
Status:
TERMINATED
Last Update Posted:
2006-05-17
First Post:
2006-05-15
Brief Title:
Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture a Randomised Controlled Trial
Status:
TERMINATED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Nonsurgical proximal humerus fracture is common causing prolonged disability for which the time to begin rehabilitation is not well determined We assessed the feasibility and efficacy of early within 3 daysafter fracture mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy
Detailed Description:
Methods We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment The primary outcome was functional assessment of the shoulder Constant score at 3 months Secondary outcomes were functional assessment at 6 weeks and at 6 months change in pain on a visual analogue scale and passive range of motion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None