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NCT Number: NCT05204992

Effectiveness of Ultrasound Guided Hydro-dissection of Median Nerve in Carpal Tunnel Syndrome

60 patients with carpal tunnel syndrome will undergo ultrasound guided hydrodissection of the median nerve with follow up using Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 3, 6 and 12 months

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Ain Shams University

Cairo, Egypt

About this study

Aim of study:

to evaluate the effectiveness of ultrasound guided hydrodissection of median nerve as minimal invasive procedure in carpal tunnel syndrome

Study Design:

60 patients with a clinical diagnosis of mild-to moderate CTS will be evaluated clinically and confirmed by neurophysiological study (NCV and EMG study). patients will undergo ultrasound guided hydrodissection, from the outpatient clinic of Neurology department, Ain shams University hospitals.

Study Subjects:

Our subjects aged 25-65 years with clinical diagnosis of mild to moderate CTS .

Patients will be assessed using Boston Carpal Tunnel Syndrome Questionnaire. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS, which encompasses 2 components(4). In total, 11 questions and 8 items were evaluated for rating on the Symptom Severity Scale (SSS) and Functional Status Scale (FSS), respectively. Both subscales score from 1 to 5, with a higher score indicating a greater degree of disability.

Subjects will be excluded if they met any of this exclusion criteria: Pregnancy, Cancer, hypothyroidism , systemic infection, history of polyneuropathy, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome , history of previous carpal tunnel open surgery or local steroid injection and severe CTS (confirmed by el electrophysiological studies)

Ultrasound-guided hydrodissection using ultrasonography (MyLab 5, Esaote, Italy) with a 5-10 MHZ linear array probe will be done by the same experienced doctor. The probe is placed in the flexor surface of the wrist at pisiform-scaphoid level to detect median nerve at the inlet of carpal tunnel with the probe oriented in the transverse (anatomic axial ) plane of carpal tunnel. A 25-guage needle is inserted from ulnar side advancing to the radial side via the in-plane approach. Hydrodissection fluid( 5 cc normal saline, 2 ml steroids, 1 ml bupivicaine) is injected in the plane between median nerve and transverse carpal ligament to separate the nerve from the deep surface of flexor retinaculum (using the jet of injected fluid from the needle tip)

Primary outcome:

Change from baseline of severity of symptoms and functional status on 3rd , 6th and 12 months month after injection [ Time Frame: Pre-treatment, 3rd,6th and 12th month after injection ] using Boston Carpal Tunnel Syndrome Questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with clinical diagnosis of mild to moderate CTS and confirmed by neurophysiological studies.
  • The clinical symptoms and signs of CTS are as follows:
  • sensory symptoms in the form of paresthesia, dysesthesia, pain and numbness of the hand in the distribution of median nerve which was more nocturnal, postural or related to hand overuse and relieved by frequent shaking of the hand
  • motor symptoms in the form of decreased strength of the thenar muscles
  • positive Phalen and/or Tinel sign.

Exclusion criteria

  • Pregnancy
  • Cancer
  • hypothyroidism
  • systemic infection
  • history of polyneuropathy
  • cervical radiculopathy
  • brachial plexopathy
  • thoracic outlet syndrome
  • history of previous carpal tunnel open surgery or local steroid injection and severe CTS (confirmed by el electrophysiological studies)

Treatment and study plan

ultrasound guided hydrodissection

Procedure

Injection of steroids, saline and bupivicaine ultrasound guided

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    Time frame: 12 months

    Boston Carpal Tunnel Syndrome Questionnaire, highest score is 95, lowest score is 19, higher score denotes worse outcome

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Ahmed ElSadek
  • Iman Hamed

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
Feb 5, 2024

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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