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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Trigger Finger; De Quervains Tenosynovitis
• Intervention / Treatment: Drug: 1ml of triamcinolone (40mg/1ml)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Matt Jones; Phone Number: 07763846709; Email: m.jones16@nhs.net
• Study Contact Backup: Name: Charles Gozzard; Email: charlesgozzard@nhs.net

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Recruiting
      • University Hospitals Plymouth NHS Trust
      • Contact: Chris Rollinson, PhD; Phone Number: 01752431045; Email: crollinson@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Corticosteroid injection; Single injection of 1ml of triamcinolone (40mg/1ml)	Drug: 1ml of triamcinolone (40mg/1ml); Single injection of 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); Single injection of 1ml of triamcinolone (40mg/1ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
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.	Immediate
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.	3 hours

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Charles Gozzard, MD, University Hospitals Plymouth NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2020
• Primary Completion (ANTICIPATED): August 15, 2023
• Study Completion (ANTICIPATED): August 15, 2023

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Local anaesthetic; Corticosteroid injection; Pain VAS Score
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Tendinopathy; Tendon Entrapment; Carpal Tunnel Syndrome; Tenosynovitis; Trigger Finger Disorder; De Quervain Disease; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: 259336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No