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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00326794
Enrollment
76
Registered
2006-05-17
Start date
2002-10-31
Completion date
2005-09-30
Last updated
2006-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Fracture

Keywords

Nonsurgical proximal humerus fracture, Rehabilitation, Physiotherapy, 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 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.

Interventions

PROCEDUREmobilisation (rehabilitation)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026