NCT00326794

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

May 17, 2006

Status Verified

June 1, 2005

First QC Date

May 15, 2006

Last Update Submit

May 15, 2006

Conditions

Shoulder Fracture

Keywords

Nonsurgical proximal humerus fractureRehabilitationPhysiotherapyrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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.

Interventions

mobilisation (rehabilitation)PROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Impacted nonsurgically treated proximal humerus fracture
  • Patients over the age 20

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marie-Martine Lefevre-colau, MDPhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

October 1, 2002

Study Completion

September 1, 2005

Last Updated

May 17, 2006

Record last verified: 2005-06

Locations

FR(1)