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

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ClinicalTrials.gov Identifier: NCT02809261
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, 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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Ultrasound-guided perineural injection with 5% dextrose Procedure: Ultrasound-guided perineural injection with normal saline Drug: Normal Saline Drug: 5% Dextrose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017


Arm Intervention/treatment
Experimental: Perineural injection with 5% dextrose
Ultrasound-guided perineural injection with 5% Dextrose (3cc) between proximal carpal tunnel and median nerve.
Procedure: 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.

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

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

Drug: Normal Saline
Normal saline is safe for perineural injection.




Primary Outcome Measures :
  1. Change from baseline of pain on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. [ Time Frame: 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 :
  1. Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. [ Time Frame: 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

  2. Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809261


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yung-Tsan Wu, Attending physician of physical medicine and rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02809261     History of Changes
Other Study ID Numbers: TSGHIRB No: 2-105-05-033
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Carpal Tunnel Syndrome
Perineural injection
Dextrose
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries