NCT06272682

Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study

Systemic Versus Local Corticosteroids in the Treatment of Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study.
Hospital Italiano de Buenos Aires·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Carpal Tunnel Syndrome
Drug/Device/Intervention
Systemic bethametasone injection
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Hospital Italiano de Buenos Aires
Location
Buenos Aires, Argentina
Timeline & enrollment
Phase
N/A
Start date
Jul 17, 2023
End date
Oct 11, 2025
Enrollment
106 participants
Primary outcome

Compare the Boston Carpal Tunnel Syndrome Questionnaire

Summary

The goal of this prospective, randomised, controlled, non-inferiority analytical study is to
 compare the Boston score in patients treated with systemic (intramuscular) versus local
 infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18
 years of age with mild or moderate carpal tunnel syndrome.
 
 The main questions it aims to answer are:
 
 - What is the effectiveness of intramuscular injection of corticosteroids compared to
 local infiltration in the treatment of mild/moderate carpal tunnel syndrome?
 
 - What are the adverse effects and application site pain associated with each route of
 administration?
 
 Patients who meet the inclusion criteria will be asked to participate in the study and sign
 an informed consent form.
 
 The Redcap randomizer will be used to assign the patient to one of the branches.
 
 Researchers will compare
 
 - Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under
 ultrasound
 
 - Branch B: patients treated with intramuscular corticosteroid injection.
 
 Researchers will:
 
 - Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and
 12 months post-procedure.
 
 - Describe adverse reactions associated with the route of administration.
 
 - Compare the pain at the site of application associated with the route of administration.

ICD-10 classifications
Carpal tunnel syndromeTarsal tunnel syndromeArthrosis of first carpometacarpal joint, unspecifiedArthrosis of first carpometacarpal jointOther specified disorders of synovium and tendon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06272682
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06272682 through Pure Global AI's free database. This phase not specified trial is sponsored by Hospital Italiano de Buenos Aires and is currently Recruiting. The study focuses on Carpal Tunnel Syndrome. Target enrollment is 106 participants.

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