- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326794
Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
May 15, 2006 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment
76
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75014
- Hôpital Cochin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
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Secondary Outcome Measures
Outcome Measure |
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Functional assessment at 6 weeks and at 6 months
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Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
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Passive range of motion at 6 weeks, 3 months and at 6 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marie-Martine Lefevre-colau, MDPhD, APHP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
May 15, 2006
First Submitted That Met QC Criteria
May 15, 2006
First Posted (Estimate)
May 17, 2006
Study Record Updates
Last Update Posted (Estimate)
May 17, 2006
Last Update Submitted That Met QC Criteria
May 15, 2006
Last Verified
June 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P011022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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