Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, Perineural injection, Dextrose
Brief summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.
Detailed description
After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.
Interventions
PROCEDUREUltrasound-guided perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
PROCEDUREUltrasound-guided perineural injection with normal saline
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
DRUGNormal Saline
Normal saline is safe for perineural injection.
DRUG5% Dextrose
5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20-85 year-old. * Diagnosis was confirmed using an electrophysiological study and ultrasonography
Exclusion criteria
Cancer * Coagulopathy * Pregnancy * Inflammation status * Cervical radiculopathy * Polyneuropathy, brachial plexopathy * Thoracic outlet syndrome * Previously undergone wrist surgery or steroid injection for CTS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment |
| Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. |
Countries
Taiwan
Outcome results
None listed