The Effect of Hydrodissection for Carpal Tunnel Syndrome

Tri-Service General Hospital

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Ultrasound-guided hydrodissection; Procedure: Placebo ultrasound-guided injection; Device: Ultrasound; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02991001

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. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection 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 and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. 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 week, 1st, 2nd and 3rd month after the treatment.

Enrollment: 34 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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

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34 participants in 2 patient groups, including a placebo group

Normal saline hydrodissection

Experimental group

Description:

Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.

Treatment:

Device: Ultrasound

Procedure: Ultrasound-guided hydrodissection

Drug: Normal Saline

Normal saline

Placebo Comparator group

Description:

Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region

Treatment:

Device: Ultrasound

Procedure: Placebo ultrasound-guided injection

Drug: Normal Saline