The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome

Tri-Service General Hospital20 enrolled

Overview

Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare. We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

Sono-guided injection with high molecular weight hyaluronic acidPROCEDURE

Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve

Sono-guided injection with low molecular weight hyaluronic acidPROCEDURE

Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Taipei, Neihu, Taiwan

Outcomes

Primary Outcomes

Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 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.