NCT05204992

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

January 7, 2022

Last Update Submit

February 2, 2024

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hydrodissection

EXPERIMENTAL

ultrasound guided hydrodissection

Procedure: ultrasound guided hydrodissection

Interventions

ultrasound guided hydrodissectionPROCEDURE

Injection of steroids, saline and bupivicaine ultrasound guided

Hydrodissection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Neurology

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 24, 2022

Study Start

April 1, 2022

Primary Completion

July 6, 2022

Study Completion

July 6, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

EG(1)