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TerminatedNCT00326794Updated May 17, 2006

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

A Phase 3 interventional study of mobilisation (rehabilitation) in Shoulder Fracture, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-05-17.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Fracture

Keywords

  • Nonsurgical proximal humerus fracture
  • Rehabilitation
  • Physiotherapy
  • randomised controlled trial
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 76 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
76 participants

Interventions

  • Proceduremobilisation (rehabilitation)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Functional assessment at 6 weeks and at 6 months

  2. Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months

  3. Passive range of motion at 6 weeks, 3 months and at 6 months.

07

Study locations

1 site
  • Hopital Cochin
    Paris, 75014, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00326794
Lead sponsor
Assistance Publique - Hôpitaux de Paris
First posted
May 17, 2006
Start date
Oct 2002
Completion
Sep 2005
Last update
May 17, 2006

Study contacts

Marie-Martine Lefevre-colau, MDPhD
principal investigator · APHP
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.

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