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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Shoulder Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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mobilisation (rehabilitation)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Marie-Martine Lefevre-colau, MDPhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Hopital Cochin

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P011022

Identifier Type: -

Identifier Source: org_study_id