Rotator Cuff Tear Arthropathy Clinical Trial
Official title:
Do Ultrasound Guided Botulinum A Injections Relieve Pain in Rotator Cuff Arthropathy?
Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Specialist shoulder replacements have found acceptance within the trust, nationally and internationally although there are high complication rates. There is however a significant cost difference (fifty fold) between a reverse total shoulder replacement and a botox injection, and to date there have been no randomised control trials, or any registered, comparing the use of a botox injection for pain relief in cuff arthropathy versus no treatment. If there is a significant clinical difference in the pain outcomes between the two, this could result in significant savings to the NHS and the taxpayer as a whole. If high levels of pain relief could be predictably obtained using Botulinum A toxin injections then potentially patients could avoid the need for surgery.
Null Hypothesis This is a pilot / feasability study. The null hypothesis is that there is no
effect on the pain or oxford shoulder scores reported by patients receiving a targeted
botulinum A toxin injection in the presence of cuff arthropathy at 6 weeks, 3 months or 6
months compared with the baseline values.
Objectives The aim of this feasability study is to provide the necessary information for the
planning of a future trial. It will test the feasibility of running such a trial and provide
estimates of the differences in outcome measures and information on resource data.
All potential participants for this study will be identified by an Orthopaedic Shoulder
Consultant in the shoulder clinics run at the Royal Devon and Exeter NHS Trust. The patients
will be screened for eligibility by a research associate (SG). The eligibility criteria will
be that the patient is medically fit for an operation, and has painful rotator cuff
arthropathy, that is deemed suitable for intervention by the consultant surgeon. The patients
will be informed verbally and in writing about the trial by the research associate and
informed consent will be taken.
The participating patients will be allocated to an USS guided botox injection. All patients
will be asked to complete a number of questionnaires prior to the injection: the Oxford
Shoulder Score (OSS), a Visual Analogue Score (VAS) and the EQ-5D. The range of movement of
the shoulder joint will be documented in the usual fashion.
The injections will all be done by Dr Anaspure (Consultant Radiologist) under USS guidance in
a standard manner.
After the injection, patients will be reviewed using the range of movement, OSS, a patient
satisfaction score and EQ-5D at 6 weeks, 3 months and 6 months post injection. A record will
be kept of any complications associated with the treatment. This data will be collected by
the research associate, who is independent of either intervention.
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