Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599086
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Efficacy of Steroid Injection in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
USG-guided Steroid Injection Treatment Efficacy of in Patients With Bifid Median Nerve Diagnosed Carpal Tunnel Syndrome Versus With Non-bifid Median Nerve Diagnosed Carpal Tunnel SyndromeA Single-blind Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Various median nerve anatomical variations have been reported in the literatureOne of these is the bifid median nerveDue to its relatively higher cross-sectional area it can facilitate compression of the median nerve in the carpal tunnelTherefore bifid median nerve is relatively common in patients with CTSSome studies have shown that the bifid median nerve has an effect on surgical failure in the treatment of carpal tunnel syndromeApart from surgical treatment perineural injection with corticosteroids is a treatment method that has been used for a long time in the treatment of mild and moderate carpal tunnel syndromeIt is controversial whether bifid median nerve has a negative effect on treatment effectivenessWhen looking at the literature there is no previous study on this subjectWith the introduction of ultrasound into our daily practice the frequency of ultrasound-guided perineural injections has increasedUltrasound allowed us to see variations in the median nerve before injectionThe aim of the study is to compare the effectiveness of steroid injection in patients with CTS with bifid median nerve and patients with CTS with non-variant median nerveIt is also to investigate whether this anatomical variation has a negative effect on the treatment
Detailed Description:
Our study was designed as a prospective single-blind randomized controlled studyPatients with an electrophysiological diagnosis of moderate CTS who applied to Etlik City Hospital Physical Therapy outpatient clinic will be included in the studyThere are no sensitive groupsThe research period was determined as 1 yearSample size was calculated using the statistical power analysis programme G Power 3194 for windowsBased on the study by Walker FOthe minimum number of patients required to achieve a significant change of 20 mm in VAS assesment before and after treatmentwith a 5 Type 1 and Type 2 margin of error 80 working power and 95 confidence interval was found to be 17total 34 patients for each groupConsidering the possibility of 20 loss during the studyıt was decided to include at least 20total 40 patients for each groupDemographic and clinical characteristics of Patients who met the inclusion criteria and completed the Informed Volunteer Consent Forum will be recordedThe general pain of the patients will be evaluated with Visual Analog ScalaThe symptom severity and functional status of the patients will be evaluated with the Boston Carpal Tunnel QuestionnaireThe patients hand grip strength measurement will be evaluated with a dynamometerThe patient hand diagram will be marked according to the patients sensory symptomsMedian nerve cross-sectional area will be measured at the pisiform level with ultrasound Distal motor latency and sensory nerve conduction velocity will be recorded with EMGPre-injection baseline assessments of participants will be made by a blinded investigator In all patients the median nerve will be visualized with ultrasound with a 12 MHz linear probe at the scaphoid-pisiform levelAfterwards perineural injection2cc1cc 2 lidocaine hidroclorid1cc betamethasone will be performed using an in-plane approach around the median nerve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None