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NCT Number: NCT02809261

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, Neihu District, 886, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided perineural injection with 5% dextrose

Procedure

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

Procedure

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

normal saline

Drug

Normal saline is safe for perineural injection.

5% Dextrose

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

The Long-term Effect of Perineural Injection Therapy in Patients With Carpal Tunnel

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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