NCT05725460

Brief Summary

to compare the efficacy of dextrose 5% with steroid hydrodissection in patients with carpal tunnel syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

September 29, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

January 23, 2023

Last Update Submit

September 27, 2023

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

dextrose 5%

EXPERIMENTAL

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

Procedure: dextrose 5% median nerve hydrodissection

steroid

ACTIVE COMPARATOR

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

Procedure: dextrose 5% median nerve hydrodissection

Interventions

dextrose 5% median nerve hydrodissectionPROCEDURE

planned to be a good alternative to steroid hydrodissection

dextrose 5%steroid

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe carpal tunnel syndrome failed medical management -

You may not qualify if:

  • previous failed surgery previous failed injection previous failed trial of hydrodissection cervical or brachial nerve entrapment wrist osteoarthritis or rheumatoid pregnant diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baghdad Medical City

Baghdad, 10001, Iraq

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups comparing the efficacy of dextrose water 5 % in median nerve hydrodissection
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 13, 2023

Study Start

February 1, 2023

Primary Completion

August 23, 2023

Study Completion

September 13, 2023

Last Updated

September 29, 2023

Record last verified: 2023-05

Locations

IR(1)