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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
  Purpose

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 Intervention Phase
Shoulder Fracture
 Procedure: mobilisation (rehabilitation)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 76
Study Start Date: October 2002
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
DRRC  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00326794     History of Changes
Other Study ID Numbers: P011022
Study First Received: May 15, 2006
Last Updated: May 15, 2006
Health Authority: France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on June 18, 2013