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The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome

T

Tri-Service General Hospital

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: Sono-guided injection with normal saline
Procedure: Sono-guided injection with hyaluronic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03031054
HA 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. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.

Full description

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. 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 finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Enrollment

35 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

35 participants in 2 patient groups

hyaluronic acid hydrodissection
Experimental group
Description:
Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
Treatment:
Procedure: Sono-guided injection with hyaluronic acid
Normal saline hydrodissection
Active Comparator group
Description:
Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
Treatment:
Procedure: Sono-guided injection with normal saline

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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