Efficacy of Shoulder Mobilisation Versus Conventional Imm... | NCT00326794

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

NCT00326794

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

May 17, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Shoulder Fracture

Interventions

mobilisation (rehabilitation)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

May 15, 2006

First Submission Date that Met QC Criteria

May 15, 2006

First Posted Date

May 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2006

Last Update Posted Date

May 17, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
mobilisation (rehabilitation)	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Martine Lefevre-colau, MDPhD	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Cochin		Paris		75014	France

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D000070599	Shoulder Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided