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

Primary Purpose

Shoulder Fracture

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

mobilisation (rehabilitation)

About this trial

This is an interventional treatment trial for Shoulder Fracture focused on measuring Nonsurgical proximal humerus fracture, Rehabilitation, Physiotherapy, randomised controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hopital Cochin

Outcomes

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.

Full Information

NCT ID

NCT00326794

First Posted

May 15, 2006

Last Updated

May 15, 2006

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00326794

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2005

Overall Recruitment Status

Terminated

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Fracture

Keywords

Nonsurgical proximal humerus fracture, Rehabilitation, Physiotherapy, randomised controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

76 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

mobilisation (rehabilitation)

Primary Outcome Measure Information:

Title

The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.

Secondary Outcome Measure Information:

Title

Functional assessment at 6 weeks and at 6 months

Title

Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months

Title

Passive range of motion at 6 weeks, 3 months and at 6 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Martine Lefevre-colau, MDPhD

Organizational Affiliation

APHP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Cochin

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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