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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014