Clinical trial NCT04253457: The SToICAL Study - The Soft Tissue Injection of Corticosteroid And Local Anaesthetic Study
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carpal Tunnel Syndrome
De Quervains Tenosynovitis
Trigger Finger
Keywords: Pain VAS Score
Corticosteroid injection
Local anaesthetic
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain visual analog scale scores at 1 hour
timeFrame: 1 hour
Secondary outcomes:
measure: Pain visual analog scale scores during 24 hours
timeFrame: 24 hours
measure: Pain visual analog scale score at the time of injection
timeFrame: Immediate
measure: Pain and functional loss
timeFrame: 3 hours
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
state: Devon
Study officials:
affiliation: University Hospitals Plymouth NHS Trust
name: Charles Gozzard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.