Systemic Versus Local Corticosteroids in the Treatment of Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 years and older

• Clinical diagnosis of mild/moderate idiopathic Carpal Tunnel Syndrome (paresthesias in the territory of the median nerve: in fingers 1, 2, 3 and radial border of 4 of the hand, nocturnal hand pain, and Positive Tinel's test, or Positive Phalen's test, or Positive Durkan's test)

• Diagnosis by electromyography and sensory and motor conduction velocity of mild/moderate involvement

• Patients who have agreed to participate in the study and signed the informed consent form.

Locations
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2025-10-11
Participants
Target number of participants: 106
Treatments
Experimental: Branch A: Local corticosteroid infiltration under ultrasound
One dose. 1 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6mg/2ml
Experimental: Branch B: treated with intramuscular corticosteroid injection
One dose. 2 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6m/2ml.
Sponsors
Leads: Hospital Italiano de Buenos Aires

This content was sourced from clinicaltrials.gov