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

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ClinicalTrials.gov Identifier: NCT03177915
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Pain, Chronic Drug: Hylase Drug: Saline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017


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 Name: ( 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 Name: (group II)




Primary Outcome Measures :
  1. pain alleviation [ Time Frame: 6 months ]
    improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10


Secondary Outcome Measures :
  1. Changes in ultrasound imaging [ Time Frame: 6 months ]
    change of cross sectional area in cubic mellimeter



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177915


Locations
Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

Responsible Party: Emad Zarief , MD, lecturer of anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT03177915     History of Changes
Other Study ID Numbers: IRB00008406
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Chronic Pain
Disease
Pathologic Processes
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