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

NCT06272682 | Recruiting

• 1 other identifier: 6669
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

clinical trial; corticosteroid infiltration; carpal tunnel syndrome; betamethasone

Outcome Measures

Primary Outcomes (1)

• Compare the Boston Carpal Tunnel Syndrome Questionnaire

  Compare the Boston Carpal Tunnel Syndrome Questionnaire in patients treated with systemic (intramuscular) versus local infiltration corticosteroids Two scales: * Symptom severity scale (11 questions): sum of the score of each question divided by the number of questions, with the lower limit and lower severity1 , and the upper limit and higher severity 5 * Functional status scale (8 questions): sum of the score of each question divided by the number of questions, with the lower limit and lower severity 1, and the upper limit and higher severity 5.

  12 months

Secondary Outcomes (2)

• Adverse reactions

  12 months

• Pain at the site of application

  12 months

Study Arms (2)

Branch A: Local corticosteroid infiltration under ultrasound

EXPERIMENTAL

One dose. 1 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6mg/2ml

Procedure: Local bethametasone injection

Branch B: treated with intramuscular corticosteroid injection

EXPERIMENTAL

One dose. 2 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6m/2ml.

Procedure: Systemic bethametasone injection

Interventions

Systemic bethametasone injection PROCEDURE

betamethasone intramuscular injection in the treatment of carpal tunnel syndrome

Branch B: treated with intramuscular corticosteroid injection

Local bethametasone injection PROCEDURE

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

Branch A: Local corticosteroid infiltration under ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cervical radiculopathy, polyneuropathy, brachial plexus pathologies, thoracic operculum syndrome
• Systemic diseases causing secondary Carpal Tunnel Syndrome (rheumatoid arthritis, diabetes with polyneuropathy, hypothyroidism with low adherence to treatment, chronic renal disease)
• Chronic corticosteroid therapy or regular use of non-steroidal anti-inflammatory drugs
• Severe carpal tunnel syndrome: signs of thenar atrophy, daytime pain, sensory deficit in median nerve territory (two-point discrimination test \>10mm)
• Previous history of wrist or distal radius fracture
• Corticosteroid allergies
• Pregnancy

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1199, Argentina

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomised, controlled, non-inferiority analytical study

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 22, 2024
• Study Start: July 17, 2023
• Primary Completion: August 11, 2024
• Study Completion: October 11, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)