The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome
The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2017
CompletedDecember 19, 2017
December 1, 2017
11 months
June 10, 2016
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of pain on 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.
Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary Outcomes (2)
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
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
Study Arms (2)
Perineural injection with 5% dextrose
EXPERIMENTALUltrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
Perineural injection with normal saline
PLACEBO COMPARATORUltrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.
Interventions
Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Normal saline is safe for perineural injection.
5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
Eligibility Criteria
You may qualify if:
- Age between 20-85 year-old.
- Diagnosis was confirmed using an electrophysiological study and ultrasonography
You may not qualify if:
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886, Taiwan
Related Publications (4)
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.
PMID: 21623291RESULTTsui 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.
PMID: 15138901RESULTTsui 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.
PMID: 15920223RESULTWu 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.
PMID: 28778254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician of physical medicine and rehabilitation
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 22, 2016
Study Start
May 1, 2016
Primary Completion
March 30, 2017
Study Completion
March 30, 2017
Last Updated
December 19, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will share