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

Shoulder Fracture Clinical Trial

Official title:

Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00326794
• Other study ID #: P011022
• Status: Terminated
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: May 15, 2006
• Start date: October 2002
• Est. completion date: September 2005

Study information

• Verified date: June 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fracture
• Shoulder Fractures

Intervention

Procedure:
• mobilisation (rehabilitation)

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
Secondary	Functional assessment at 6 weeks and at 6 months
Secondary	Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
Secondary	Passive range of motion at 6 weeks, 3 months and at 6 months.