Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00326794

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Fractures Rehabilitation Shoulder Injuries and Disorders

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

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Nonsurgical proximal humerus fracture
Rehabilitation
Physiotherapy
randomised controlled trial

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Humeral Fractures
Arm Injuries
Shoulder Fractures

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Humeral Fractures
Arm Injuries
Shoulder Fractures

ClinicalTrials.gov processed this record on September 01, 2009