Clinical Trials Directory

Trials / Completed

CompletedNCT06725420

Ultrasound-Guided Injection vs Intramuscular Steroid for Carpal Tunnel Syndrome

Comparison of the Effectiveness of Ultrasound-guided Local Steroid Injection vs Intramuscular Steroid Injection in the Treatment of Carpal Tunnel Syndrome: A Prospective, Randomized, Controlled, Single-blind Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Konya Beyhekim Training and Research Hospital · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Carpal tunnel syndrome (CTS) is the most common and disability-causing entrapment neuropathy; however, a standardized protocol for first-line management has yet to be established. Different treatment approaches have their own positive and negative aspects. The aim of this study is to compare the effectiveness of ultrasound-guided local steroid injection and intramuscular steroid injection in mild-to-moderate CTS. Patients will be assessed for pain levels, functional/symptom status, hand-finger strength, side effects, patient satisfaction, median nerve ultrasonographic measurements, and EMG before and after treatment .

Detailed description

Patients evaluated through a detailed clinical examination and medical history review according to inclusion and exclusion criteria will provide written informed consent and will be assigned to one of three treatment groups using block randomization. The patients' basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel's/Phalen's sign, sleep quality, pain intensity, electrophysiological parameters.) will be recorded. The first group (local steroid) will receive an ultrasound-guided local steroid injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The second group (intramuscular steroid) will receive a gluteal intramuscular injection (1 ml of 40 mg triamcinolone + 1 ml lidocaine) along with a nighttime wrist splint. The third group will receive only a nighttime wrist splint. All patients in the study groups were provided with prefabricated volar wrist splints to be used at night and, whenever possible, during the day for 2-3 hours. No medication or exercise therapy will be given to the patients. All groups were evaluated based on examination findings (Tinel's/Phalen's test), pain intensity (VAS day and VAS night), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire scores, sleep quality, the patient's subjective impression of improvement (satisfaction), electrophysiological parameters (two times), and ultrasound measurements (cross-sectional areas \[CSA\] and flattening ratio \[long diameter/short diameter\]) at the proximal inlet of the median nerve (at the level of the scaphoid and pisiform bones, at the level of the distal wrist crease) before treatment (baseline), at the end of treatment (two weeks), and six weeks after treatment. The evaluation parameters/outcomes will be made by the same researcher blind to the groups. Patients will be questioned about undesirable effects at the end of the 2nd and 6th weeks after the treatment.

Conditions

Interventions

TypeNameDescription
OTHERUltrasound-guided local InjectionUltrasound-Guided steroid injection and splinting in patients with carpal tunnel syndrome
OTHERIntramuscular Steroid InjectionIntramuscular gluteal steroid injection and Splinting in Patients With Carpal Tunnel Syndrome
DEVICESplintingwrist night splint

Timeline

Start date
2024-12-10
Primary completion
2025-09-19
Completion
2025-10-24
First posted
2024-12-10
Last updated
2026-03-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06725420. Inclusion in this directory is not an endorsement.