Effectiveness of Ultrasound Guided Hydro-dissection of Median Nerve in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided hydrodissection
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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:
- 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)
Sites / Locations
- Faculty of medicine Ain Shams University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydrodissection
Arm Description
ultrasound guided hydrodissection
Outcomes
Primary Outcome Measures
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Boston Carpal Tunnel Syndrome Questionnaire, highest score is 95, lowest score is 19, higher score denotes worse outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05204992
First Posted
January 7, 2022
Last Updated
January 30, 2023
Sponsor
Ain Shams University
Collaborators
Ahmed ElSadek, Iman Hamed
1. Study Identification
Unique Protocol Identification Number
NCT05204992
Brief Title
Effectiveness of Ultrasound Guided Hydro-dissection of Median Nerve in Carpal Tunnel Syndrome
Official Title
Effectiveness of Ultrasound Guided Hydro-dissection of Median Nerve in Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Ahmed ElSadek, Iman Hamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrodissection
Arm Type
Experimental
Arm Description
ultrasound guided hydrodissection
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided hydrodissection
Intervention Description
Injection of steroids, saline and bupivicaine ultrasound guided
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Description
Boston Carpal Tunnel Syndrome Questionnaire, highest score is 95, lowest score is 19, higher score denotes worse outcome
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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:
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)
Facility Information:
Facility Name
Faculty of medicine Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effectiveness of Ultrasound Guided Hydro-dissection of Median Nerve in Carpal Tunnel Syndrome
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