Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Brief Title:
Comparing Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose in Carpal Tunnel Syndrome
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Comparison of the Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose at Different Volumes in Patients With Carpal Tunnel Syndrome A Prospective Randomized Double Blind Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the efficacy of ultrasonography-guided hydrodissection technique with 5 dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome
Detailed Description:
Carpal tunnel syndrome CTS is the most common peripheral nerve entrapment neuropathy worldwide resulting from the compression of the median nerve in the carpal tunnel an osteofibrous canal whose roof is formed by the flexor retinaculum and whose floor is formed by the carpal bones CTS accounts for approximately 90 of all entrapment neuropathies and an individuals lifetime risk of diagnosis is estimated to be 10 It is estimated that about 5 of the population suffers from CTS It is more common in women compared to men and at least half of the cases manifests between the ages of 40 and 60
In clinical practice the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve These complaints which initially occur and flare up at night and intermittently during the day may become continuous and worsen in the later stages of the disease
Taking an accurate history and clinical assessment is crucial for diagnosis Evaluation of sensory abnormalities loss of two point discrimination and the strength of abductor pollicis brevis muscle can provide information about functional impairment Tinels sign and Phalens manoeuvre are some of diagnostic tests Some scales and questionnaires are used in diagnosis and assessment of functionality Ultrasonography is a useful inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage Nerve conduction studies are considered the gold standard method in diagnosis determining prognosis and making treatment decisions
The management of CTS in patients depends on the severity of the disease In mild and moderate circumstances conservative treatments are recommended for the patients Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments Conservative treatments include patient education wrist splinting medical treatments physical therapy and perineural injections
Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid planeVarious injectates such as normal saline 5 dextrose and platelet-rich plasmaviscosupplements are commonly used for hydrodissection Many studies have been conducted with the hypothesis that the injection volume in addition to the injection preparation would also be important in median nerve hydrodissection and different results have been obtained
This study aimed to compare the clinical ultrasonographic and electrophysiological improvement in patients by applying different volumes of dexamethasone and dextrose in median nerve hydrodissection Patients will be evaluated before and after treatment at 2nd 4th and 12th weeks ultrasonographically electrophysiologically and clinically with pain scores handgrip strength assesment two-point discrimination values functional and disability scales
In clinical practice the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve These complaints which initially occur and flare up at night and intermittently during the day may become continuous and worsen in the later stages of the disease
Taking an accurate history and clinical assessment is crucial for diagnosis Evaluation of sensory abnormalities loss of two point discrimination and the strength of abductor pollicis brevis muscle can provide information about functional impairment Tinels sign and Phalens manoeuvre are some of diagnostic tests Some scales and questionnaires are used in diagnosis and assessment of functionality Ultrasonography is a useful inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage Nerve conduction studies are considered the gold standard method in diagnosis determining prognosis and making treatment decisions
The management of CTS in patients depends on the severity of the disease In mild and moderate circumstances conservative treatments are recommended for the patients Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments Conservative treatments include patient education wrist splinting medical treatments physical therapy and perineural injections
Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid planeVarious injectates such as normal saline 5 dextrose and platelet-rich plasmaviscosupplements are commonly used for hydrodissection Many studies have been conducted with the hypothesis that the injection volume in addition to the injection preparation would also be important in median nerve hydrodissection and different results have been obtained
This study aimed to compare the clinical ultrasonographic and electrophysiological improvement in patients by applying different volumes of dexamethasone and dextrose in median nerve hydrodissection Patients will be evaluated before and after treatment at 2nd 4th and 12th weeks ultrasonographically electrophysiologically and clinically with pain scores handgrip strength assesment two-point discrimination values functional and disability scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None