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Ultrasound Guided Median Nerve Hydrodissection Using Dextrose

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
dextrose 5% median nerve hydrodissection
Sponsored by
Iraqi Board of medical specialties
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: severe carpal tunnel syndrome failed medical management - Exclusion Criteria: previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus -

Sites / Locations

  • Baghdad Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dextrose 5%

steroid

Arm Description

10 mls of dextrose under ultrasound to separate the median nerve from adjacent structures

10 mls of steroid used to separate the median nerve from adjacent structures

Outcomes

Primary Outcome Measures

pain relief in 2 weeks follow up
difference in sensory and functional symptoms post median nerve hydrodissection using dextrose and compare this effect with steroid population arm using Boston questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 23, 2023
Last Updated
September 27, 2023
Sponsor
Iraqi Board of medical specialties
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1. Study Identification

Unique Protocol Identification Number
NCT05725460
Brief Title
Ultrasound Guided Median Nerve Hydrodissection Using Dextrose
Official Title
Efficacy of Dextrose 5% in Comparison With Steroid in Median Nerve Ultrasound Guided Hydrodissection in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 23, 2023 (Actual)
Study Completion Date
September 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iraqi Board of medical specialties

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
to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome
Detailed Description
in some cases there is prohibition to use steroid with example the patient rejection to use steroid the maneuver planned median nerve hydrodissection using ultrasound and 10 mld of dextrose 5%, unleash the median nerve for the surrounding structure and short follow up planned to be 2 weeks

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
Parallel Assignment
Model Description
2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dextrose 5%
Arm Type
Experimental
Arm Description
10 mls of dextrose under ultrasound to separate the median nerve from adjacent structures
Arm Title
steroid
Arm Type
Active Comparator
Arm Description
10 mls of steroid used to separate the median nerve from adjacent structures
Intervention Type
Procedure
Intervention Name(s)
dextrose 5% median nerve hydrodissection
Intervention Description
planned to be a good alternative to steroid hydrodissection
Primary Outcome Measure Information:
Title
pain relief in 2 weeks follow up
Description
difference in sensory and functional symptoms post median nerve hydrodissection using dextrose and compare this effect with steroid population arm using Boston questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: severe carpal tunnel syndrome failed medical management - Exclusion Criteria: previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus -
Facility Information:
Facility Name
Baghdad Medical City
City
Baghdad
ZIP/Postal Code
10001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ultrasound Guided Median Nerve Hydrodissection Using Dextrose

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