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Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy?

NCT02512536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Rotator Cuff Tear Arthropathy

Interventions

DRUG

Botulinum Toxin Type A

Ultrasound scan guided injection into supraspinatus muscle belly with Botulinum Toxin Type A

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Chris Smith · Royal Devon and Exeter NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-11-22
Completion
2017-11-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02512536 on ClinicalTrials.gov