Clinical Trials Directory

Trials / Completed

CompletedNCT05204992

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREultrasound guided hydrodissectionInjection of steroids, saline and bupivicaine ultrasound guided

Timeline

Start date
2022-04-01
Primary completion
2022-07-06
Completion
2023-07-06
First posted
2022-01-24
Last updated
2024-02-05

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05204992. Inclusion in this directory is not an endorsement.