Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03675295

Enrollment

Registered

2018-09-18

Start date

2017-04-02

Completion date

2018-07-01

Last updated

2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Brief summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Detailed description

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Interventions

DRUGHyalase

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

DRUGSaline

injection of 10 cc saline injection nearby median nerve as hydro-dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* adult patients * complaining of carpal tunnel syndrome of 3 month duration or more * diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion criteria

* patient refusal * infection at the site of intervention * local anesthetic allergy

Design outcomes

Primary

Measure	Time frame	Description
pain alleviation	6 months	visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary

Measure	Time frame	Description
Changes in ultrasound imaging	6 months	change of cross sectional area of the median nerve
Changes in median nerve conduction parameters	6 months	distal motor latency, sensory nerve conduction velocity,peak sensory latency

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026