The SToICAL Study
Research type
Research Study
Full title
The Soft Tissue Injection of Corticosteroid And Local anaesthetic Study - A Single site, non-inferiority randomised control trial evaluating pain after soft tissue corticosteroid injections with and without local anaesthetic
IRAS ID
259336
Contact name
Charles Gozzard
Contact email
Sponsor organisation
University Hospitals Plymouth NHS Trust
Eudract number
2019-003742-32
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Some hand conditions can be treated with a steroid injection. Some doctors mix the steroid with local anaesthetic in the hope that the patient will experience less pain after the injection. Some doctors do not do this. It is not known if adding local anaesthetic to the steroid improves patients pain after the injection. This trial will assess pain after steroid injections into the hand and wrist, given with or without local anaesthetic. If the trial shows that using local anaesthetic improves patients’ pain then we should continue using it. If not, we should stop giving patients unnecessary medication, which would also save the NHS time and money.
All patients over the age of 18 years old with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome will be considered for the trial. Eligible patients attending clinic at the University of Plymouth Hospital Trust will be given information and time in the clinic to decide whether they would like to participate. If they agree to participate they would have the injection in clinic but would not know if they were getting the steroid injection with local anaesthetic or not.
Patients will be asked to record their pain score on a form at the time of the injection; at 5 minutes, 1-hour, 2-hours, 3-hours and 24-hours after the injection. After completing this they will return the form by post in a prepaid envelope. After this, there are no further patient requirements and follow-up would happen routinely regardless whether they participated or not.
The primary outcome will be to investigate whether there is difference in pain Visual Analogue Score at 1-hour after a steroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome given with or without local anaesthetic.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0232
Date of REC Opinion
17 Jan 2020
REC opinion
Further Information Favourable Opinion