Shoulder FracturePhase 3NCT00326794
Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
A Phase 3 study testing mobilisation (rehabilitation) in people with Shoulder Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Fracture
- What is being tested?
- mobilisation (rehabilitation)
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2002to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impacted nonsurgically treated proximal humerus fracture
- Patients over the age 20
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
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.
- Conditions
- Shoulder Fracture
- Being tested
- mobilisation (rehabilitation)
- Keywords
- Nonsurgical proximal humerus fracture, Rehabilitation, Physiotherapy, randomised controlled trial
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilisation (rehabilitation)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startOct 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FractureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 76 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Marie-Martine Lefevre-colau, MDPhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326794
- Sponsor's protocol ID
- P011022
- Status last verified
- Jun 2005
- First submitted
- 15 May 2006
- Last updated
- 17 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT00326794
- Acronym / sponsor ID
- P011022
- Conditions
- Shoulder Fracture
- Keywords
- Nonsurgical proximal humerus fracture, Rehabilitation, Physiotherapy, randomised controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 76 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Sep 2005
- First posted
- 17 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impacted nonsurgically treated proximal humerus fracture
- Patients over the age 20
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobilisation (rehabilitation) | Procedure or surgery | – |
Primary outcome
The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
3 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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2006.
Related trials for Shoulder Fracture
RecruitingObservational study
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
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Study on Outcomes of Proximal Humerus Fractures
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Comparison of Surgical Techniques for Anterior Shoulder Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Martine Lefevre-colau, MDPhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mobilisation (rehabilitation) in people with Shoulder Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2006.