Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253457
Recruitment Status : Suspended (COVID-19)
First Posted : February 5, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome De Quervains Tenosynovitis Trigger Finger Drug: 1ml of triamcinolone (40mg/1ml) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : February 26, 2022
Estimated Study Completion Date : August 26, 2022


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)




Primary Outcome Measures :
  1. Pain visual analog scale scores at 1 hour [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pain visual analog scale scores during 24 hours [ Time Frame: 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.

  2. Pain visual analog scale score at the time of injection [ Time Frame: Immediate ]
    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.

  3. Pain and functional loss [ Time Frame: 3 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253457


Locations
Layout table for location information
United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, Devon, United Kingdom, PL6 8DH
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Charles Gozzard, MD University Hospitals Plymouth NHS Trust
  Study Documents (Full-Text)

Documents provided by University Hospital Plymouth NHS Trust:
Informed Consent Form  [PDF] January 7, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT04253457    
Other Study ID Numbers: 259336
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University Hospital Plymouth NHS Trust:
Pain VAS Score
Corticosteroid injection
Local anaesthetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Trigger Finger Disorder
Tenosynovitis
De Quervain Disease
Carpal Tunnel Syndrome
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
Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs