Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome

NCT03177915 | Completed

• 1 other identifier: IRB00008406
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• pain alleviation

  improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

  6 months

Secondary Outcomes (1)

• Changes in ultrasound imaging

  6 months

Study Arms (2)

Hyalase

ACTIVE COMPARATOR

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

Drug: Hylase

Saline

ACTIVE COMPARATOR

Injection 10 cc saline injection as a median nerve hydro-dissection

Drug: Saline

Interventions

Hylase DRUG

median nerve hydro-dissection using Hyalase + 10 cc saline injection

Also known as: ( group I )

Hyalase

Saline DRUG

median nerve hydro-dissection using 10 cc saline injection

Also known as: (group II)

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Chronic Pain

Interventions

hylase; Sodium Chloride

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and ICU

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 6, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)