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

Tri-Service General Hospital

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Ultrasound-guided perineural injection with 5% dextrose; Drug: Normal Saline; Procedure: Ultrasound-guided perineural injection with normal saline; Drug: 5% Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02809261

TSGHIRB No: 2-105-05-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Perineural injection with 5% dextrose

Experimental group

Description:

Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.

Treatment:

Drug: 5% Dextrose

Procedure: Ultrasound-guided perineural injection with 5% dextrose

Perineural injection with normal saline

Placebo Comparator group

Description:

Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.

Treatment:

Drug: Normal Saline

Procedure: Ultrasound-guided perineural injection with normal saline