Comparison of Difference Hydrodissection for CTS

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Ultrasound-guided short-axis hydrodissection with 5cc normal saline; Procedure: Ultrasound-guided long-axis hydrodissection with 3cc normal saline

• Registration Number: NCT03031041
• Lead Sponsor: 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. 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 trial to assess the effect of different method of ultrasound-guided hydrodissection in patients with CTS.

Detailed Description

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in short-axis group received one-dose ultrasound-guided hydrodissection with short-axis approach and long-axis group received one-dose ultrasound-guided injection with long-axis approach. 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, 2nd, 3rd and 6th month after the treatment.

Study Timeline

• Study First Submitted: 2017-01-21
• Study First Submitted QC: 2017-01-21
• Study Start: 2017-01-25
• Study First Posted: 2017-01-25
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-axis hydrodissection	Ultrasound-guided short-axis hydrodissection with 5cc normal saline	Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve
Long-axis hydrodissection	Ultrasound-guided long-axis hydrodissection with 3cc normal saline	Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve

Primary Outcome Measures

Name	Time	Method
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection	Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection	Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection	Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection	Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection	Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection	Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection	Electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection	Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection	The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan