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Clinical Trials/NCT00326794
NCT00326794
Terminated
Phase 3

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country76 target enrollmentOctober 2002

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Shoulder Fracture
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
76
Locations
1
Primary Endpoint
The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
Status
Terminated
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
September 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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.

Study Sites (1)

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