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The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome

The Long-term Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990962
Enrollment
54
Registered
2016-12-13
Start date
2016-12-31
Completion date
2018-04-01
Last updated
2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

perineural injection, ultrasound-guided, dextrose, steroid

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 including steroid injection. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. The investigators design a randomized, double-blind, controlled trail to assess the effect of ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared with steroid injection.

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 steroid. 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 week, 1st, 2nd, 3rd and 6 month after the treatment.

Interventions

Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.

DRUG1cc 2% Xylocaine+4cc Triamcinolone (40mg)

Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injectionUsing the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

Secondary

MeasureTime frameDescription
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injectionUsing the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injectionUsing the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injectionNerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026