Clinical trial NCT04766918: The Effect of Different Molecular Weight of HA for Carpal Tunnel Syndrome
Official title: The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Hydrodissection
hyaluronic acid
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Secondary outcomes:
measure: Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
measure: Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
measure: Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
measure: Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection
timeFrame: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, School of Medicine, National Defense Medical Center
state: Neihu
Study officials:
References:
citation: Ozgenel GY. Effects of hyaluronic acid on peripheral nerve scarring and regeneration in rats. Microsurgery. 2003;23(6):575-81. doi: 10.1002/micr.10209.
citation: Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP. Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. J Surg Res. 1995 Dec;59(6):644-52. doi: 10.1006/jsre.1995.1218.
citation: Ozgenel GY, Filiz G. Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg. 2003 Feb;98(2):371-7. doi: 10.3171/jns.2003.98.2.0371.
citation: Atzei A, Calcagni M, Breda B, Fasolo G, Pajardi G, Cugola L. Clinical evaluation of a hyaluronan-based gel following microsurgical reconstruction of peripheral nerves of the hand. Microsurgery. 2007;27(1):2-7. doi: 10.1002/micr.20299.