Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03017105 |
| Other study ID # |
5222 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
November 2019 |
Study information
| Verified date |
January 2023 |
| Source |
Liverpool University Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Proximal humerus fractures (break of the top part of the upper arm bone) are common in older
people with poorer bone quality. Often patients do not undergo surgery for these fractures:
the bone fragments may be in an acceptable enough position to be able to heal naturally, or
the patient may not be well enough medically to undergo an operation. These patients need to
wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly
when they are unable to be used. This research project will look at whether strength-training
the opposite/uninjured limb, known as "cross education", has any effect on preserving the
function of the injured/fractured limb. Participants will be randomised into two groups using
minimisation, that is to say the groups will have balanced numbers in terms of exact pattern
of fracture and gender. One group will receive traditional rehabilitation exercises and
treatment by the physiotherapist for their injured limb; the other group will receive the
same but in addition will also undergo a strength-training exercise programme for their
uninjured limb. Only qualified physiotherapists with experience of treating this patient
cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes
each and will comprise of: patient review, exercise progression, and advice giving/question
answering; home exercise programmes will be expected to be completed 2-3 times daily and last
up to 30 minutes each; number of sessions will be agreed between the participant and treating
physiotherapist with treating ending once an agreed, acceptable level of function has been
achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the
participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks
after commencement of treatment.
Description:
This study will investigate the use of cross education (ie. strength-training the uninjured
limb) as part of the recovery and return to function for skeletally mature, adult patients as
measured by the Oxford Shoulder Score after proximal humerus fracture and answer the
question:
does the use of a strength-training programme for the non-injured limb affect return to
function in adult patients with proximal humerus fractures?
Proximal humerus fractures (break to the top part of the upper arm bone) are common,
accounting for 4-6% of all fractures in the older population and almost one-fifth of all
fractures sustained after a fall from a standing height in patients with osteoporosis. These
fractures can functionally impair the upper limb and so impact on overall quality of life.
Some studies show that a number of previously fit and independent patients may not return to
independent activity following a proximal humerus fracture and may even be at increased risk
for sustaining a subsequent fractured hip/neck of femur. If new rehabilitation approaches can
help improve the level of function achieved the morbidity and quality of life of these
patients could potentially be improved.
The ageing population of the United Kingdom means the number of patients sustaining these
fractures will increase and so increase the cost to the National Health Service and the risk
of morbidity/mortality/disability/poor health-related quality of life. Treatment needs to
address range of movement (ROM) and muscle strength as well as restoration of function and
access to the community as quickly as possible. Effective, timely and cost-efficient
management of these patients must be found.
Patients with proximal humerus fractures generally undergo a period of wearing a sling to
immobilise the limb/stop them from moving it- especially those being managed without an
operation. Different orthopaedic and physiotherapy teams across the UK use different periods
of immobilisation, start rehabilitation at different times after injury and use different
rehabilitation methods. Only a few randomised controlled trials (RCTs) exist looking into
when to start physiotherapy and exactly what physiotherapy to do. Studies are needed to
develop treatment and rehabilitation protocols to deliver the best and most cost-effective
patient care possible.
Wearing a sling/immobilisation of a limb for as little as one week can cause significant
muscle wastage resulting in loss of strength and loss of function. Studies have shown that
there is up to 60% reduction in strength after 5-6 weeks immobilisation. This early decline
in strength could be due to fewer nerve signals being sent from the brain to the inactive
muscles. It has been suggested that this could be prevented by strength-training the
uninjured limb, known as "cross-education". The exact mechanisms by which it works are still
unknown but it is thought that using cross-education could help maintain messages sent from
the brain and so minimise changes in muscle and facilitating quicker recovery. The body works
reciprocally in many ways, for example swinging the opposite arm (to the stepping leg) whilst
walking. Many studies have already been done that show an improvement/maintenance of strength
of an immobilised limb after strength-training the opposite limb but these studies have
looked at uninjured patients or at those with lower limb injuries. Research into using the
principle of cross-education with upper limb injuries is needed before it can be applied in
practice routinely to patients.
The patient will be asked some questions by the Specialist Physiotherapist or Doctor during
their fracture clinic appointment to see whether they are eligible to take part in the study.
If eligible they will have be provided with a written information sheet and the clinician
will explain the study and answer any questions they may have.
Patients will receive a phone call from the primary researcher 24-48 hours after being
provided with the study information to answer any further questions they may have and to
gauge interest in participation in the trial. If they are keen to be involved the primary
researcher will arrange for them to come into the Physiotherapy department to sign a written
consent form. At this appointment (which will take place in a clinical office within the
department) the primary researcher will then use a computer programme (called Minim) to
allocate them into one of the two study groups. If they are allocated into the experimental
group the primary researcher will teach them their strengthening exercises for their
uninjured limb, and will then arrange their first follow up physiotherapy appointment for
within the next 2-3 weeks. Patients allocated to the control group (standard rehabilitation)
will be booked their first physiotherapy appointment after signing their consent form. The
patient will also be asked to complete some questionnaires about their current level of
function/pain/etc.- these are completed by all patients suffering this particular injury
regardless of participation in the study.
All participants will have ongoing physiotherapy treatment at as many appointments as are
deemed necessary in agreement with themselves and the treating physiotherapist to return to
their required level of function. Those in the experimental group will receive a
strength-training regime for they uninjured limb in addition to usual rehabilitation for the
injured limb. Those in the control group will receive usual rehabilitation for the injured
limb. All participants will be required to complete further questionnaires at 6 and 12 weeks
after the initial questionnaires were completed (as is the case for all patients receiving
physiotherapy at this Trust).
