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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound-guided perineural injection with 5% dextrose
Ultrasound-guided perineural injection with normal saline
Normal Saline
5% Dextrose
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Perineural injection, Dextrose

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perineural injection with 5% dextrose

Perineural injection with normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in severity of symptoms and functional status on 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.
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

Full Information

First Posted
June 10, 2016
Last Updated
December 18, 2017
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02809261
Brief Title
The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome
Official Title
The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Perineural injection, Dextrose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perineural injection with 5% dextrose
Arm Type
Experimental
Arm Description
Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
Arm Title
Perineural injection with normal saline
Arm Type
Placebo Comparator
Arm Description
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and median nerve.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided perineural injection with 5% dextrose
Intervention Description
Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided perineural injection with normal saline
Intervention Description
Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal saline is safe for perineural injection.
Intervention Type
Drug
Intervention Name(s)
5% Dextrose
Intervention Description
5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary Outcome Measure Information:
Title
Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment
Title
Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
21623291
Citation
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.
Results Reference
result
PubMed Identifier
15138901
Citation
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.
Results Reference
result
PubMed Identifier
15920223
Citation
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.
Results Reference
result
PubMed Identifier
28778254
Citation
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.
Results Reference
derived

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

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