Early vs. delayed physical therapy (exercises) for non-operatively treated proximal humerus fractures: A multicenter prospective randomized trial

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.

The Hand and Upper Extremity Unit of the Massachusetts General Hospital (MGH)
is a referral center for complex post-traumatic problems and therefore sees
many patients with a proximal humerus non-union that have been referred from
peripheral hospitals. It is possible that a concern regarding a so-called
*frozen shoulder* may be leading surgeons to recommend initiation of exercises
too early resulting in healing problems. The surgeons of the MGH Orthopaedic
Hand and Upper extremity service believe that more data is needed with regard
to this question and have started a prospective comparative trial between
immediate and delayed exercises for regaining shoulder motion after proximal
humerus fracture.

The Trauma Unit of the Academic Medical Center in Amsterdam agrees with the
necessity for more data regarding this matter, has been invited by the MGH to
collaborate on this study, and would like to be added as a study site to be
able to enroll patients in this trial, turning it into a multicenter trial.

The main objective is to analyse whether or not active forward flexion of the
shoulder six months after non-operative treatment of a proximal humerus
fracture is better when physical therapy is initiated directly (within 3 weeks
after injury and before fracture healing has become established) than when it
is initiated between 4 and 8 weeks after injury (when early fracture healing is
apparent clinically and/or radiographically).

The secondary objective is to determine if there are differences in several
functional outcome measures (DASH, Likert Score, Constant score, abduction,
internal and external rotation) six months after fracture between the two
groups.

This study is a prospective, randomized controlled clinical trial comparing two
treatment options; early vs. late physisical therapy in nonoperatively treated
patients with proximal humerus fractures.

One group receives physical therapy immediately (within 3 weeks after injury),
the other group receives physical therapy once healing has occurred clinically
and/or radiographically (4-8 weeks after injury).

The treatment that patients will receive is the standard treatment of care in
the United States, which currently depends on the surgeon*s preference to write
a prescription for physical therapy (or instruct patients to begin moving the
arm) to start either immediately (within 3 weeks of injury) or not until early
healing is established (between 4 and 8 weeks after injury) as determined by
the treating surgeon by examination and radiographs. In the Netherlands the
standard treatment usually consists of a direct start of the shoulder
excersises. Both start dates are likely to benefit the patients and both are
considered standard treatment in the United States depending on the physician*s
preference. In the Netherlands, as previously stated, a direct start of
shoulder excercises is generally considered the standard treatment of care.
Further benefit will be to future patients with this problem as this data may
improve understanding of this illness.
Patients will have to fill in a DASH form during all three visits (enrollment
and two follow-up dates) which will take approximately 10 minutes of their
time, depending on how fast they can read. The assessment of the range of
motion of the shoulder will take approximately five minutes during the second
and third follow-up visits. The quantity and type of pain medication used will
be asked and registered.
The risks are comparable to those that the standard treatment involves. Close
follow up and a protocol of treatment, identical to the standard one, will be
applied in every subject. Reduction of risks will be done according to
inclusion and exclusion criteria.
If complications arise, the treating physician will proportionate the adequate
treatment according to the current protocols of treatment based on the
published literature.

Subjects could experience mild discomfort during physical examination and
testing, but this will be no different from physical examination during routine
follow-up.

There will be no direct benefit to patients enrolled in the trial. We expect
society as a whole to benefit from better evidence for determining the choice
of rehabilitation protocol.