Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189651
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-19
Brief Title:
Short Term Efficacy of 5 Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in CTS
Sponsor:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Organization:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Overview
Official Title:
Short-Term Efficacy of 5 Dextrose Injection With Ultrasound Guided Nerve Hydrodissection Method in Carpal Tunnel Syndrome Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Hydrodissection injection method It is a safe and effective injection method in peripheral nerve compression that aims to release the adhesions by separating the nerve from the surrounding connective tissues through the liquid given by injection Perineural injection of 5 dextrose is analgesic in neuropathic pain although the mechanism is not fully defined USG-guided 5 dextrose injection using nerve hydrodissection method is promising in the treatment of CTS In our study we aimed to investigate the short-term 4 weeks efficacy of 5 dextrose injection using USG-guided nerve hydrodissection method in combination with wrist splint treatment in patients with mild to moderate carpal tunnel syndrome CTS and whether this treatment can provide additional benefit to wrist splint treatment
Detailed Description:
In our prospective randomized controlled study 44 patients who met the inclusion criteria and had mild to moderate carpal measured syndrome with EMG as described in previous studies were included in the study The 44 volunteer participants with mild to moderate carpal tunnel syndrome were randomly divided into 2 groups as wrist splint treatment group control group and wrist splint 5 dextrose injection treatment group study group by stratified and block randomization method Stratified randomization was done according to the variable of having mild and moderate carpal tunnel syndrome Assignment to the treatment or control group for each stratum was done by 11 block randomization
All patients were given the same type of wrist splint to be used for at least 8 hours at night for 4 weeks to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist and activities that aggravate symptoms repetitive and demanding wrist movements Knitting keyboard use use of vibrating tools etc were recommended to be avoided The given wrist splint is a commercially available wrist splint with a metal bar on the palmar side and Velcro straps on the dorsal side that can be adjusted according to the wrist restricting flexion and extension of the wrist and allowing movement of the metacarpophalangeal joint Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up All patients were given a wrist splint diary and asked to write down the days and hours of splinting Patients who did not wear splints for enough days and hours were excluded from the study In the study group 2 ml each of 5 dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance After the application the spread of the injectate was observed by looking longitudinally at the median nerve A 25 gauge syringe was used for administration Patients were observed for side effects and side effects were noted Patients were asked to rate their injection pain on a Visual Analog Scale VAS after injection to measure the pain during injection All patients were advised not to take any additional treatment for their symptoms during the study Patients who received additional treatment were noted All patients were evaluated with Visual Analog Scale VAS score Turkish version of Boston Carpal Tunnel Questionnaire BCTQ grip strength GS measured by hand dynamometer and median nerve cross-sectional area CSA measured by ultrasonography before the start of the study week 0 and at the end of the 4th week
All patients were given the same type of wrist splint to be used for at least 8 hours at night for 4 weeks to be worn in a neutral position and in accordance with the wrist as described in previous studies to restrict movement in the wrist and activities that aggravate symptoms repetitive and demanding wrist movements Knitting keyboard use use of vibrating tools etc were recommended to be avoided The given wrist splint is a commercially available wrist splint with a metal bar on the palmar side and Velcro straps on the dorsal side that can be adjusted according to the wrist restricting flexion and extension of the wrist and allowing movement of the metacarpophalangeal joint Patients who did not sleep for 8 hours were asked to complete 8 hours of wrist splint use before going to sleep or after waking up All patients were given a wrist splint diary and asked to write down the days and hours of splinting Patients who did not wear splints for enough days and hours were excluded from the study In the study group 2 ml each of 5 dextrose injection was administered once at the proximal wrist level above the median nerve separating the median nerve from the flexor retinaculum and below the median nerve separating the median nerve from the flexor tendons by nerve hydrodissection method in the transverse inplane plane under ultrasound guidance After the application the spread of the injectate was observed by looking longitudinally at the median nerve A 25 gauge syringe was used for administration Patients were observed for side effects and side effects were noted Patients were asked to rate their injection pain on a Visual Analog Scale VAS after injection to measure the pain during injection All patients were advised not to take any additional treatment for their symptoms during the study Patients who received additional treatment were noted All patients were evaluated with Visual Analog Scale VAS score Turkish version of Boston Carpal Tunnel Questionnaire BCTQ grip strength GS measured by hand dynamometer and median nerve cross-sectional area CSA measured by ultrasonography before the start of the study week 0 and at the end of the 4th week
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