Clinical Trial: Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: May 15, 2006
Date Started: October 2002
Date Completion: September 2005
Last Updated: May 15, 2006
Last Verified: June 2005
