Evaluation of Corticosteroid use in Carpal Tunnel Syndrome Surgery

Comparison of carpal tunnel Decompression with and without Corticosteroid: a randomized clinical trial - BETTER-CTS Betamethasone Enhancement for Tunnel Treatment and Early Recovery in Carpal Tunnel Syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-3rt39sj

Enrollment

Unknown

Registered

2025-12-01

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal tunnel syndrome

Interventions

This is a randomized, controlled, and double-blinded clinical study in two arms. Simple electronic randomization. Carpal tunnel decompression occurs under optical magnification, with a median longitud

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients - over 18 years of age; of both sexes; diagnosed with Carpal Tunnel Syndrome (CTS) and requiring surgery; recruited from the surgical referral system of Rio Grande do Norte.

Exclusion criteria

Exclusion criteria: Patients with skin lesions at the surgical site. Users of long-term systemic corticosteroids. Patients with decompensated psychiatric disorders. Patients with decompensated diabetes mellitus.

Design outcomes

Primary

Measure	Time frame
A significant improvement is expected in the sum of the 11 symptom items and 8 functionality items of the Boston Carpal Tunnel Questionnaire at 6 months with corticosteroid use versus placebo.	—

Secondary

Measure	Time frame
A significant improvement is expected in the sum of the 11 symptom items and 8 functionality items of the Boston Carpal Tunnel Questionnaire within 1 month with corticosteroid use versus placebo.;A significant improvement is expected in the sum of the 11 symptom items and 8 functionality items of the Boston Carpal Tunnel Questionnaire within 3 months with corticosteroid use versus placebo.;A significant improvement in the surgery satisfaction questionnaire is expected within 6 months. Operative complications;It is expected that there will be a significantly lower rate of operative complications, such as infection and postoperative pain, within 6 months.;A significant improvement in median nerve conduction velocity is expected to be found in electromyography within 6 months.	—

Measure

Time frame

A significant improvement is expected in the sum of the 11 symptom items and 8 functionality items of the Boston Carpal Tunnel Questionnaire within 1 month with corticosteroid use versus placebo.;A significant improvement is expected in the sum of the 11 symptom items and 8 functionality items of the Boston Carpal Tunnel Questionnaire within 3 months with corticosteroid use versus placebo.;A significant improvement in the surgery satisfaction questionnaire is expected within 6 months. Operative complications;It is expected that there will be a significantly lower rate of operative complications, such as infection and postoperative pain, within 6 months.;A significant improvement in median nerve conduction velocity is expected to be found in electromyography within 6 months.

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Countries

Brazil

Contacts

Public ContactGuilherme Lima

Hospital Universitário Onofre Lopes

guilhermelimaneurocirurgia@gmail.com+5584933425000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)