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

Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Pain, Chronic
• Intervention / Treatment: Drug: Hylase; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyalase; injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection	Drug: Hylase; median nerve hydro-dissection using Hyalase + 10 cc saline injection; Other Names: ( group I )
Active Comparator: Saline; Injection 10 cc saline injection as a median nerve hydro-dissection	Drug: Saline; median nerve hydro-dissection using 10 cc saline injection; Other Names: (group II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ultrasound imaging	change of cross sectional area in cubic mellimeter	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Chronic Pain
• Other Study ID Numbers: IRB00008406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No