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Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture

This study has been terminated.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00326794
First received: May 15, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted

May 15, 2006
May 15, 2006
October 2002
Not Provided
The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
Same as current
No Changes Posted
  • Functional assessment at 6 weeks and at 6 months
  • Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
  • Passive range of motion at 6 weeks, 3 months and at 6 months.
Same as current
Not Provided
Not Provided
 
Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
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 days’after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Shoulder Fracture
Procedure: mobilisation (rehabilitation)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
76
September 2005
Not Provided

Inclusion Criteria:

  • Impacted nonsurgically treated proximal humerus fracture
  • Patients over the age 20

Exclusion Criteria:

  • Pre-existing shoulder pathology
  • Neurological disorders of the upper limbs
  • Indication for surgery of the shoulder
  • Combined polytrauma
  • Difficulties with language or comprehension to understand a rehabilitation program and information
Both
20 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00326794
P011022
Not Provided
Not Provided
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Marie-Martine Lefevre-colau, MDPhD APHP
Assistance Publique - Hôpitaux de Paris
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP