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The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Therapy | Subjects who begin therapy immediately after diagnosis of injury. | ||
| Late Therapy | Subjects who delay therapy for 3 weeks after diagnosis of injury. |
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| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Flexion | We measured active forward flexion of the shoulder | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain Likert Scores | Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain. | 3 months, 6 months |
| External Rotation | 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from the MGH Hand and Upper Extremity or Trauma service
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| Name | Affiliation | Role |
|---|---|---|
| Neal Chen, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Therapy | Subjects who begin therapy immediately after diagnosis of injury. |
| FG001 | Late Therapy | Subjects who delay therapy for 3 weeks after diagnosis of injury. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are assessed for all subjects completing 3-month follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Therapy | Subjects who begin therapy immediately after diagnosis of injury. |
| BG001 | Late Therapy | Subjects who delay therapy for 3 weeks after diagnosis of injury. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shoulder Flexion | We measured active forward flexion of the shoulder | All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up. | Posted | Mean | Standard Deviation | Degrees | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Therapy | Subjects who begin therapy immediately after diagnosis of injury. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal Chen | Massachusetts General Hospital | 6177264700 | nchen1@partners.org |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| Abduction | 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. | 3 months, 6 months |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Injured Hand | Count of Participants | Participants |
|
| Non- or minimally displaced | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Shoulder Pain Likert Scores | Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain. | All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
|
|
|
| Secondary | External Rotation | All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up. | Posted | Mean | Standard Deviation | Degrees | 3 months, 6 months |
|
|
|
| Secondary | Abduction | All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up. | Posted | Mean | Standard Deviation | Degrees | 3 months, 6 months |
|
|
|
| Secondary | 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. | All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up. | Posted | Mean | Standard Deviation | Units on a scale | 3 months, 6 months |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Late Therapy | Subjects who delay therapy for 3 weeks after diagnosis of injury. | 0 | 24 | 0 | 24 | 0 | 24 |
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