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
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00326794
P011022
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