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

NCT06272682 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Carpal Tunnel Syndrome

Interventions

PROCEDURE

Systemic bethametasone injection

betamethasone intramuscular injection in the treatment of carpal tunnel syndrome

PROCEDURE

Local bethametasone injection

Local betamethasone injection under ultrasound in the carpal tunnel, in the treatment of carpal tunnel syndrome

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2024-08-11
Completion
2025-10-11

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272682 on ClinicalTrials.gov