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Completed

NCT Number: NCT03675295

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

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

20 year–80 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

Hyalase

Drug

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

Saline

Drug

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

Primary outcomes

  1. pain alleviation

    Time frame: 6 months

    visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary outcomes

  1. Changes in ultrasound imaging

    Time frame: 6 months

    change of cross sectional area of the median nerve

  2. Changes in median nerve conduction parameters

    Time frame: 6 months

    distal motor latency, sensory nerve conduction velocity,peak sensory latency

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2018
Registry last updated
Sep 18, 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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