Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT04253457
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.
Study:
NCT04253457
Study Brief:
Protocol Section:
NCT04253457