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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Trigger Finger, Carpal Tunnel Syndrome, De Quervains Tenosynovitis

Intervention / Treatment
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* Drug: 1ml of triamcinolone (40mg/1ml)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid injection<br>Single injection of 1ml of triamcinolone (40mg/1ml) | Drug: 1ml of triamcinolone (40mg/1ml)<br>* Single injection of 1ml of triamcinolone (40mg/1ml)<br>|
| Active Comparator: Corticosteroid and local anaesthetic injection<br>Single injection of 1ml of triamcinolone (40mg/1ml) + 1ml 1% Lidocaine | Drug: 1ml of triamcinolone (40mg/1ml)<br>* Single injection of 1ml of triamcinolone (40mg/1ml)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain VAS Score, Corticosteroid injection, Local anaesthetic