Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04579783
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2020-09-27
Brief Title:
Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
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:
Carpal tunnel syndrome CTS is the most prevalent peripheral nerve entrapment of upper limb Typical symptoms comprise pain numbness or tingling of the thumb and index middle or ring fingers Thumb weakness and decreased grip strength can occur in the later stage Currently treatments included physical modalities low power laser transcutaneous electrical nerve stimulation ultrasound medication splinting injection and surgery Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization while the injectates were diverse Corticosteroid has been widely used for CTS for decades However growing evidences suggested that 5 dextrose normal saline platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms Among the injectates a single 5 dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months However the clinical efficacy of 5 dextrose injection has not validated by the further study The investigators aim to compare the therapeutic effect of 5 dextrose injection with corticosteroid injection in patients with CTS up to 12 weeks follow up
Detailed Description:
Introduction
Carpal tunnel syndrome CTS is the most prevalent peripheral nerve entrapment of upper limb Typical symptoms comprise pain numbness or tingling of the thumb and index middle or ring fingers Thumb weakness and decreased grip strength can occur in the later stage Currently treatments included physical modalities low power laser transcutaneous electrical nerve stimulation ultrasound medication splinting injection and surgery Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization while the injectates were diverse Corticosteroid has been widely used for CTS for decades However growing evidences suggested that 5 dextrose normal saline platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms Among the injectates a single 5 dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months However the clinical efficacy of 5 dextrose injection has not validated by the further study Whether repeated injection could expand the treatment effect was undetermined The investigators aim to compare the therapeutic effect repeated 5 dextrose injection with corticosteroid injection in patients with CTS up to 12 weeks follow up
Material and methods
Participants 60 adult patients 20 year olds with carpal tunnel syndrome recruited from outpatient clinic
Inclusion criteria Presenting with CTS symptoms including nocturnal postural or motion-associated paresthesias - pain of the median nerve distribution area in the subjective hand Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree Persistent symptoms for more than 3 months
Exclusion Criteria Patients cervical radiculopathy polyneuropathy brachial plexopathy thoracic outlet syndrome Recent corticosteroid injection to the carpal tunnel within 6 months
Thenar muscle atrophy Previous history of carpal tunnel surgical release History of wrist trauma Regular use of systemic nonsteroidal anti-inflammatory drugs corticosteroids or diuretics Pregnancy Cognitive impairment
Objective
The aim of this study is to compare the treatment effect of repeated 5 mL 5 dextrose with 5mL triamcinolone acetonide injection in patients with CTS
Detail of the intervention The study is designated as randomized double blinded and parallel experiment The randomization was decided by random table in block of 4
Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5 dextrose Group B or 5mL triamcinolone acetonide injection Group A in patients with CTS
The regimen was shown as below
Group A 1st injection 0 week 40mg triamcinolone acetonide 40mgmL with 4mL normal saline 2nd injection 6 week 5 mL normal saline Group B 1st injection 0 week 5 mL 5 dextrose 2nd injection 6 week 5 mL 5 dextrose
Skin infiltration with local anesthetic lidocaine cream at the needle insertion site was performed before the injection Then injection was performed after sterilization The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe
Outcome measurement
Boston Carpal Tunnel Syndrome Questionnaire BCTQ and Visual analogue scale VAS before 1st injection before 2nd injection 6-week and 12-week after first injection
Electrophysiological evaluation amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential cross-sectional area of median nerve at carpal tunnel inlet were evaluated before and 12-week after 1st injection
Global assessment of treatment was evaluated at before 2nd injection 6-week and 12-week after first injection
Statistical analysis
Continuous variables Students t test fit assumption of normal distribution Mann-Whitney test does not fit the assumption of normal distribution Categorical variables 1 Chi-square test 2 Fisher exact test sparse data 3Repeated-measures analysis of variance ANOVA was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame
Keywords Hydro-dissection corticosteroid dextrose carpal tunnel syndrome
Carpal tunnel syndrome CTS is the most prevalent peripheral nerve entrapment of upper limb Typical symptoms comprise pain numbness or tingling of the thumb and index middle or ring fingers Thumb weakness and decreased grip strength can occur in the later stage Currently treatments included physical modalities low power laser transcutaneous electrical nerve stimulation ultrasound medication splinting injection and surgery Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization while the injectates were diverse Corticosteroid has been widely used for CTS for decades However growing evidences suggested that 5 dextrose normal saline platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms Among the injectates a single 5 dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months However the clinical efficacy of 5 dextrose injection has not validated by the further study Whether repeated injection could expand the treatment effect was undetermined The investigators aim to compare the therapeutic effect repeated 5 dextrose injection with corticosteroid injection in patients with CTS up to 12 weeks follow up
Material and methods
Participants 60 adult patients 20 year olds with carpal tunnel syndrome recruited from outpatient clinic
Inclusion criteria Presenting with CTS symptoms including nocturnal postural or motion-associated paresthesias - pain of the median nerve distribution area in the subjective hand Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree Persistent symptoms for more than 3 months
Exclusion Criteria Patients cervical radiculopathy polyneuropathy brachial plexopathy thoracic outlet syndrome Recent corticosteroid injection to the carpal tunnel within 6 months
Thenar muscle atrophy Previous history of carpal tunnel surgical release History of wrist trauma Regular use of systemic nonsteroidal anti-inflammatory drugs corticosteroids or diuretics Pregnancy Cognitive impairment
Objective
The aim of this study is to compare the treatment effect of repeated 5 mL 5 dextrose with 5mL triamcinolone acetonide injection in patients with CTS
Detail of the intervention The study is designated as randomized double blinded and parallel experiment The randomization was decided by random table in block of 4
Repeated ultrasound guided injection intracarpal median nerve hydro-dissection with 5 mL 5 dextrose Group B or 5mL triamcinolone acetonide injection Group A in patients with CTS
The regimen was shown as below
Group A 1st injection 0 week 40mg triamcinolone acetonide 40mgmL with 4mL normal saline 2nd injection 6 week 5 mL normal saline Group B 1st injection 0 week 5 mL 5 dextrose 2nd injection 6 week 5 mL 5 dextrose
Skin infiltration with local anesthetic lidocaine cream at the needle insertion site was performed before the injection Then injection was performed after sterilization The equipment for ultrasound-guided injection will be high-resolution ultrasound machine with the linear probe
Outcome measurement
Boston Carpal Tunnel Syndrome Questionnaire BCTQ and Visual analogue scale VAS before 1st injection before 2nd injection 6-week and 12-week after first injection
Electrophysiological evaluation amplitude and distal latency of median nerve compound motor action potential and sensory nerve action potential cross-sectional area of median nerve at carpal tunnel inlet were evaluated before and 12-week after 1st injection
Global assessment of treatment was evaluated at before 2nd injection 6-week and 12-week after first injection
Statistical analysis
Continuous variables Students t test fit assumption of normal distribution Mann-Whitney test does not fit the assumption of normal distribution Categorical variables 1 Chi-square test 2 Fisher exact test sparse data 3Repeated-measures analysis of variance ANOVA was used to evaluate the effect of injection with post-hoc Bonferroni test to evaluate intra-group data at different time-frame
Keywords Hydro-dissection corticosteroid dextrose carpal tunnel syndrome
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