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TerminatedNCT04253457SToICALUpdated Sep 17, 2026

The SToICAL Study - The Soft Tissue Injection of Corticosteroid And Local Anaesthetic Study

A Phase 3 interventional study of 1ml of triamcinolone (40mg/1ml) in Carpal Tunnel Syndrome, De Quervains Tenosynovitis and Trigger Finger, sponsored by University Hospital Plymouth NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Hospital Plymouth NHS Trust · Phase 3, Interventional, and Other

Why this study was terminated
Standard of Care change impacted recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 patient's pain after the injection.

The overall aim of the study is to see whether using local anaesthetic in the steroid injection makes a difference to patients' pain. If the study shows that using local anaesthetic improves patients' pain then the investigators should continue using it. If not, the investigators should stop giving patients unnecessary medication, which would also save the NHS time and money.

Read the detailed description

This study is a single site, patient and assessor blinded, non-inferiority randomised control trial of patients with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome, treated with a corticosteroid injection co-administered with or without local anaesthetic.

The aim is to determine whether pain experienced during the 24 hours after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection.

The primary outcome is to investigate whether there is a difference in pain VAS scores at 1-hour after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. Secondary outcomes look at differences in pain VAS scores within the first 24-hours after the injection, at the time of the injection and enquires about effects on hand function.

Patients attending elective hand and wrist outpatient clinics at the University Hospitals Plymouth NHS Trust with a clinical diagnosis of trigger finger, de Quervains tenosynovitis and carpal tunnel syndrome will be screen for eligibility for recruitment.

All patients over the age 18 years old with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome and who are able to give written informed consent for treatment will be included. Patients will be excluded if they have had previous surgery or corticosteroid injection for the condition being treated at the site considered for injection. A previous corticosteroid injection elsewhere in the hand does not exclude a patient from the trial. Those who are pregnant, breast-feeding or who have a history of hypersensitivity to corticosteroid or local anaesthetic will be excluded.

The study will run for a 12-month period or until 100 patients have been recruited to the trial.

02

Conditions studied

  • Carpal Tunnel Syndrome
  • De Quervains Tenosynovitis
  • Trigger Finger

Keywords

  • Pain VAS Score
  • Corticosteroid injection
  • Local anaesthetic
03

In context

Carpal Tunnel Syndrome

587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female ages >/= 18 years
  • A clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome made by a consultant physician.
  • Treatment with injection is recommended by the doctor and agreed by the patient
  • Patient is willing and able to give for participation in the study

Exclusion criteria

Exclusion Criteria:

  • Previous surgery for the condition being treated at the desired location of injection
  • Previous injection for the condition being treated at the desired location of injection
  • Clinical suspicion of local or systematic sepsis or infection
  • History of to the corticosteroid or local anaesthetic
  • Pregnant or breast-feeding females
  • Unable to understand and complete self-report questionnaires written in English
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Corticosteroid injection

    Single injection of 1ml of triamcinolone (40mg/1ml)

    Drug: 1ml of triamcinolone (40mg/1ml)

  • Active comparator
    Corticosteroid and local anaesthetic injection

    Single injection of 1ml of triamcinolone (40mg/1ml) + 1ml 1% Lidocaine

    Drug: 1ml of triamcinolone (40mg/1ml)

Interventions

  • Drug1ml of triamcinolone (40mg/1ml)

    Single injection of 1ml of triamcinolone (40mg/1ml)

06

What researchers measure

Primary outcomes

  1. Pain visual analog scale scores at 1 hour

    Investigate whether there is a difference in pain visual analog scale scores (where 0 is no pain and 10 is the worst pain possible) at 1-hour after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.

    Time frame: 1 hour

Secondary outcomes

  1. Pain visual analog scale scores during 24 hours

    Investigate whether there is a difference in pain visual analog scale scores (where 0 is no pain and 10 is the worst pain possible) during the 24-hours after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.

    Time frame: 24 hours

  2. Pain visual analog scale score at the time of injection

    Investigate whether there is a difference in the pain visual analog scale scores (where 0 is no pain and 10 is the worst pain possible) at the time of the corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.

    Time frame: Immediate

  3. Pain and functional loss

    Investigate the difference in the additional analgesia required and in the functional use of the hand during the first 3 hours following a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.

    Time frame: 3 hours

07

Study locations

1 site
  • University Hospitals Plymouth NHS Trust
    Plymouth, Devon PL6 8DH, United Kingdom
08

References and documents

Publications

  • Jones M, Evans J, Fullilove S, Doyle E, Gozzard C. The SToICAL trial: study protocol for the soft tissue injection of corticosteroid and local anaesthetic trial-a single site, non-inferiority randomised control trial evaluating pain after soft tissue corticosteroid injections with and without local anaesthetic. Trials. 2021 Sep 28;22(1):662. doi: 10.1186/s13063-021-05627-5. PubMed 34583762 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Jan 2025, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2020
First posted
Feb 5, 2020
StartActual
Feb 26, 2020
Primary completionActual
Jan 23, 2025
CompletionActual
Nov 21, 2025
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04253457
Lead sponsor
University Hospital Plymouth NHS Trust
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Feb 26, 2020
Primary completion
Jan 23, 2025
Completion
Nov 21, 2025
Last update
Sep 17, 2026

Study contacts

Charles Gozzard, MD
principal investigator · University Hospital Plymouth NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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