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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: ultrasound guided hydrodissection

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrodissection; ultrasound guided hydrodissection	Procedure: ultrasound guided hydrodissection; Injection of steroids, saline and bupivicaine ultrasound guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	Boston Carpal Tunnel Syndrome Questionnaire, highest score is 95, lowest score is 19, higher score denotes worse outcome	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Ahmed ElSadek; Iman Hamed

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: FMASU R 154/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No