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

NCT ID: NCT05204992

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-07-06

Brief Summary

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

Detailed Description

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrodissection

ultrasound guided hydrodissection

Group Type: EXPERIMENTAL

ultrasound guided hydrodissection

Intervention Type: PROCEDURE

Injection of steroids, saline and bupivicaine ultrasound guided

Interventions

ultrasound guided hydrodissection

Injection of steroids, saline and bupivicaine ultrasound guided

Intervention Type: PROCEDURE

Eligibility Criteria

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:

1. 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

2. motor symptoms in the form of decreased strength of the thenar muscles

3. 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed ElSadek

UNKNOWN

Sponsor Role: collaborator

Iman Hamed

UNKNOWN

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mai Fathy Ahmed Fahmy

Lecturer of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 154/2021

Identifier Type: -

Identifier Source: org_study_id