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Completed

NCT Number: NCT03177915

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

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hylase

Drug

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

Other names: ( group I )

Saline

Drug

median nerve hydro-dissection using 10 cc saline injection

Other names: (group II)

Primary outcomes

  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 outcomes

  1. Changes in ultrasound imaging

    Time frame: 6 months

    change of cross sectional area in cubic mellimeter

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 6, 2017
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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