Proximal Humeral FracturesNCT00438633
Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures
An observational study of Proximal Humeral Fractures, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fractures
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the MGH Hand and Upper Extremity or Trauma service
Who may be able to join
- Male and Female patients.
- Any race
- Older than 18y
- Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
- Any type of proximal humeral fracture according to the Neer or AO classification system.
- Patient should have received non-operative treatment.
Who cannot join
- Patients younger than 18 y.
- Patients with multiple other fractures.
- Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
Read the detailed description
Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.
- Conditions
- Proximal Humeral Fractures
- Keywords
- proximal humerus fracture, rehabilitation, non-operative treatment, DASH and Constant instruments
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Therapy | Subjects who begin therapy immediately after diagnosis of injury. | |
| Late Therapy | Subjects who delay therapy for 3 weeks after diagnosis of injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Flexion
We measured active forward flexion of the shoulder
Measured: 6 months
Secondary outcomes (4)
Shoulder Pain Likert Scores
Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.
Measured: 3 months, 6 months
External Rotation
Measured: 3 months, 6 months
Abduction
Measured: 3 months, 6 months
Disability of the Hand, Shoulder, and Arm Score
Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2005
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FracturesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438633
- Sponsor's protocol ID
- 2004-P-002235
- Status last verified
- Jun 2019
- First submitted
- 20 Feb 2007
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00438633
- Acronym / sponsor ID
- 2004-P-002235
- Conditions
- Proximal Humeral Fractures
- Keywords
- proximal humerus fracture, rehabilitation, non-operative treatment, DASH and Constant instruments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2005 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
Detailed description
Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Therapy | – | –Subjects who begin therapy immediately after diagnosis of injury. |
| Late Therapy | – | –Subjects who delay therapy for 3 weeks after diagnosis of injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the MGH Hand and Upper Extremity or Trauma service
Key inclusion criteria (6 listed)
- Male and Female patients.
- Any race
- Older than 18y
- Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
- Any type of proximal humeral fracture according to the Neer or AO classification system.
Key exclusion criteria (3 listed)
- Patients younger than 18 y.
- Patients with multiple other fractures.
- Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shoulder Flexion
Time frame: 6 months
We measured active forward flexion of the shoulder
4 secondary outcomes
Shoulder Pain Likert Scores
Time frame: 3 months, 6 months
External Rotation
Time frame: 3 months, 6 months
Abduction
Time frame: 3 months, 6 months
Disability of the Hand, Shoulder, and Arm Score
Time frame: 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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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.
Neal Chen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fractures, run by Massachusetts General Hospital at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jun 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Shoulder Flexion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438633, which also lists 1 linked publication.
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 21 Jun 2019.