An observational study in Proximal Humeral Fractures, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Massachusetts General Hospital · Observational
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.
109 studies on the registry are indexed under Shoulder Fractures; 27 are open to participants now.
This study's enrollment of 63 is below the median of 94 across 55 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Patients from the MGH Hand and Upper Extremity or Trauma service
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who begin therapy immediately after diagnosis of injury.
Subjects who delay therapy for 3 weeks after diagnosis of injury.
Shoulder Flexion
We measured active forward flexion of the shoulder
Time frame: 6 months
Shoulder Pain Likert Scores
Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.
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
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.
Time frame: 3 months, 6 months
| Milestone | Early Therapy | Late Therapy |
|---|---|---|
| Started | 32 | 31 |
| 3-month follow-up | 26 | 24 |
| Completed | 16 | 14 |
| Not completed | 16 | 17 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 15 | 17 |
We measured active forward flexion of the shoulder
| Degrees | Early Therapy | Late Therapy |
|---|---|---|
| Shoulder Flexion | 150 ± 26 | 146 ± 22 |
Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.
| units on a scale | Early Therapy | Late Therapy |
|---|---|---|
| NRS Pain, 3 months | 3 ± 2 | 3 ± 1 |
| NRS Pain, 6 months | 2 ± 1 | 2 ± 3 |
| Degrees | Early Therapy | Late Therapy |
|---|---|---|
| External Rotation, 3 months | 53 ± 30 | 51 ± 21 |
| External Rotation, 6 months | 70 ± 17 | 66 ± 26 |
| Degrees | Early Therapy | Late Therapy |
|---|---|---|
| Abduction, 3 months | 115 ± 43 | 101 ± 41 |
| Abduction, 6 months | 147 ± 27 | 136 ± 33 |
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.
| Units on a scale | Early Therapy | Late Therapy |
|---|---|---|
| DASH, 3 months | 33 ± 25 | 24 ± 15 |
| DASH, 6 months | 18 ± 12 | 14 ± 7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Therapy | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Late Therapy | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
Baseline characteristics are assessed for all subjects completing 3-month follow-up.
| Age, Continuous(Years) | Early Therapy | Late Therapy | Total |
|---|---|---|---|
| Mean | 63 ± 13 | 62 ± 12 | 63 ± 13 |
| Sex: Female, Male(Participants) | Early Therapy | Late Therapy | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 21 | 15 | 36 |
| Injured Hand(Participants) | Early Therapy | Late Therapy | Total |
|---|---|---|---|
| Dominant | 9 | 12 | 21 |
| Non-dominant | 17 | 12 | 29 |
| Non- or minimally displaced(Participants) | Early Therapy | Late Therapy | Total |
|---|---|---|---|
| Yes | 22 | 19 | 41 |
| No | 4 | 5 | 9 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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