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The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

T

Tri-Service General Hospital

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Drug: Normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03381521
Nerve hydrodissection for CTS

Details and patient eligibility

About

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage. However, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies Hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with CTS.

Full description

After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were inclused and randomized into three groups. Group A, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure. As a result, patients were blinded to the treatment condition. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and global assessment of treatment. The evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.

Enrollment

24 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion criteria

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Group A
Experimental group
Description:
Ultrasound-guided nerve hydrodissection with 10cc normal saline
Treatment:
Procedure: Ultrasound-guided nerve hydrodissection
Drug: Normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Device: Ultrasound
Group B
Active Comparator group
Description:
Ultrasound-guided nerve hydrodissection with 5cc normal saline
Treatment:
Procedure: Ultrasound-guided nerve hydrodissection
Drug: Normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Device: Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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