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

NCT04253457 | Suspended Phase 3

• 1 other identifier: 259336
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome; De Quervains Tenosynovitis; Trigger Finger

Keywords

Pain VAS Score; Corticosteroid injection; Local anaesthetic

Outcome Measures

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.

  1 hour

Secondary Outcomes (3)

• Pain visual analog scale scores during 24 hours

  24 hours

• Pain visual analog scale score at the time of injection

  Immediate

• Pain and functional loss

  3 hours

Study Arms (2)

Corticosteroid injection

EXPERIMENTAL

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

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

Corticosteroid and local anaesthetic injection

ACTIVE COMPARATOR

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

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

Interventions

1ml of triamcinolone (40mg/1ml) DRUG

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

Corticosteroid and local anaesthetic injection; Corticosteroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 corticosteroid injection is recommended by the doctor and agreed by the patient
• Patient is willing and able to give informed consent for participation in the study

You may not qualify if:

• Previous surgery for the condition being treated at the desired location of injection
• Previous steroid injection for the condition being treated at the desired location of injection
• Clinical suspicion of local or systematic sepsis or infection
• History of hypersensitivity to the corticosteroid or local anaesthetic
• Pregnant or breast-feeding females
• Unable to understand and complete self-report questionnaires written in English

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34583762 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; De Quervain Disease; Trigger Finger Disorder

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Charles Gozzard, MD

  University Hospitals Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 26, 2020
• Primary Completion: January 23, 2025
• Study Completion: November 21, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)