Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05204992 |
| Other study ID # |
FMASU R 154/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
July 6, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
