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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Ultrasound-guided perineural injection with 5% dextrose; Procedure: Ultrasound-guided perineural injection with normal saline; Drug: 5% Dextrose; Drug: Normal Saline

• Registration Number: NCT02809261
• Lead Sponsor: Tri-Service General Hospital

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-22
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineural injection with 5% dextrose	5% Dextrose	Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
Perineural injection with 5% dextrose	Ultrasound-guided perineural injection with 5% dextrose	Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
Perineural injection with normal saline	Ultrasound-guided perineural injection with normal saline	Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.
Perineural injection with normal saline	Normal Saline	Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan