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

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ClinicalTrials.gov Identifier: NCT00326794
Recruitment Status : Terminated
First Posted : May 17, 2006
Last Update Posted : May 17, 2006
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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 days’after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.

Condition or disease Intervention/treatment Phase
Shoulder Fracture Procedure: mobilisation (rehabilitation) Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
Study Start Date : October 2002
Estimated Study Completion Date : September 2005

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U.S. FDA Resources




Primary Outcome Measures :
  1. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.

Secondary Outcome Measures :
  1. Functional assessment at 6 weeks and at 6 months
  2. Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
  3. Passive range of motion at 6 weeks, 3 months and at 6 months.


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326794


Locations
France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie-Martine Lefevre-colau, MDPhD APHP

ClinicalTrials.gov Identifier: NCT00326794     History of Changes
Other Study ID Numbers: P011022
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: May 17, 2006
Last Verified: June 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nonsurgical proximal humerus fracture
Rehabilitation
Physiotherapy
randomised controlled trial

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries