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

NCT ID: NCT02809261

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-03-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Keywords

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Carpal Tunnel Syndrome Perineural injection Dextrose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Perineural injection with 5% dextrose

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

Group Type EXPERIMENTAL

Ultrasound-guided perineural injection with 5% dextrose

Intervention Type PROCEDURE

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

5% Dextrose

Intervention Type DRUG

5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.

Perineural injection with normal saline

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

Group Type PLACEBO_COMPARATOR

Ultrasound-guided perineural injection with normal saline

Intervention Type PROCEDURE

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

Normal Saline

Intervention Type DRUG

Normal saline is safe for perineural injection.

Interventions

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Ultrasound-guided perineural injection with 5% dextrose

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

Intervention Type PROCEDURE

Ultrasound-guided perineural injection with normal saline

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

Intervention Type PROCEDURE

Normal Saline

Normal saline is safe for perineural injection.

Intervention Type DRUG

5% Dextrose

5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending physician of physical medicine and rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yung-Tsan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Locations

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Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.

Reference Type RESULT
PMID: 21623291 (View on PubMed)

Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.

Reference Type RESULT
PMID: 15138901 (View on PubMed)

Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.

Reference Type RESULT
PMID: 15920223 (View on PubMed)

Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.

Reference Type DERIVED
PMID: 28778254 (View on PubMed)

Other Identifiers

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TSGHIRB No: 2-105-05-033

Identifier Type: -

Identifier Source: org_study_id