Rotator Cuff Tear Arthropathy Clinical Trial
Official title:
Do Ultrasound Guided Botulinum A Injections Relieve Pain in Rotator Cuff Arthropathy?
NCT number | NCT02512536 |
Other study ID # | 1510150 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | November 22, 2017 |
Verified date | February 2019 |
Source | Royal Devon and Exeter NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 22, 2017 |
Est. primary completion date | November 22, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Inclusion criteria The only eligibility criterion for participation in this study is that the patient is medically fit for an operation and diagnosed with symptomatic rotator cuff arthropathy. They must be able to give informed consent and have evidence of cuff arthropathy on plain radiographs of the affected shoulder. Exclusion Criteria: - Exclusion criteria Contra-indications to surgery (defined as severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction; severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission; any other systemic medical condition that would produce a specific contraindication to a general anaesthetic). Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as dementia or intravenous drug abuse Note: If a recruited patient requires a contra-lateral shoulder botox injection during the trial period, this second shoulder cannot be included in the study since the result of this intervention would not be independent from the first intervention. Other exclusion criteria include: Previous fractures or dislocations of the shoulder. Previous surgery on the affected shoulder. Any neurological or medical condition resulting in spasticity |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon and Exeter hospital | Exeter | Devon |
Lead Sponsor | Collaborator |
---|---|
Royal Devon and Exeter NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post injection Oxford Shoulder Scores | PROM | At 6 weeks, 3 months and 6 months after injection. | |
Secondary | Pain score | VAS | At 6 weeks, 3 months and 6 months after injection. |
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