Clinical Trials Directory

Trials / Completed

CompletedNCT05343351

Effect of Out of Plane and In Plane Injection Techniques in Patients With Carpal Tunnel Syndrome

The Effect of Out of Plane and In Plane Injection Techniques on Injection Pain and Functionality in Patients With Carpal Tunnel Syndrome Undergoing Ultrasound-Guided Injection: A Randomized, Double-Blind Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Istanbul University - Cerrahpasa · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this study, using two different injection techniques, 1. To evaluate the patients in terms of the pain they feel during the application of carpal tunnel syndrome (CTS) injection, 2. Evaluation in terms of undesirable effects developing after injection, 3. To evaluate the degree of pain/drowsiness, symptom severity and functionality, and median nerve diameter at the end of the first month after the injection, and to evaluate the relationship of these parameters with the pain felt by the patients during the injection.

Detailed description

Among the evaluated patients, the patients who met the inclusion and exclusion criteria and accepted the carpal tunnel syndrome injection will be randomized into 2 groups using the random numbers table. One group will be injected using the out-of-plane technique under ultrasound, and the other group will be injected using the in-plane technique. Patients will be evaluated before the treatment, at the 1st hour after the injection and at the end of the 4th week after the injection. Randomization and injection of the patients will be done by Dr Gül Tuğba Bulut, while the evaluation of the patients and the sonographic evaluation of the median nerve will be done by Dr Alper Mengi. Age, gender, education level, body mass index, duration of symptoms, dominant hand, injection hand, and carpal tunnel syndrome severity detected in EMG of the patients included in the study will be recorded. The patients will be questioned about the pain they feel during the injection at the end of the 1st hour after the injection, while the degree of pain/numbness in the wrist and finger, symptom severity and functionality, and median nerve diameter are evaluated at the end of the 4th week before and after the injection. Patients will be questioned about undesirable effects at the end of the 4th week after the injection.

Conditions

Interventions

TypeNameDescription
OTHERTechnique of injection methodIn 'out of plane group', the ultrasound probe will be placed at the entrance level of the proximal carpal tunnel (scaphoid-pisiform plane), the ulnar edge of the median nerve will be taken to the midpoint of the probe, and then the needle will be inserted from the middle point of the probe with the out of plane method. Then the needle will be advanced towards the ulnar side of the median nerve and the injection content will be given into the tunnel. In 'in plane group group', the ultrasound probe will be placed at the proximal carpal tunnel entrance level (scaphoid-pisiform plane), it will be entered at a cross angle between the ulnar artery and the median nerve with the in-plane method, and be advanced under the median nerve, and then the injection content will be given into the carpal tunnel.

Timeline

Start date
2022-04-01
Primary completion
2022-12-01
Completion
2023-02-21
First posted
2022-04-25
Last updated
2023-02-28

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05343351. Inclusion in this directory is not an endorsement.