NCT03394131

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

December 25, 2017

Last Update Submit

July 12, 2018

Conditions

Treatment Resistant Carpal Tunnel in RA Patients

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Visual analog scale 0-100

    6 months

Secondary Outcomes (2)

  • nerve conduction

    6 months

  • ultrasound

    6 months

Study Arms (3)

Hyalase

EXPERIMENTAL

injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided

Drug: Hylase

Placebo

PLACEBO COMPARATOR

injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided

Other: saline

Insilin

ACTIVE COMPARATOR

injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided

Drug: Insulin

Interventions

HylaseDRUG

hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline

Also known as: Hyaluronidase
Hyalase
InsulinDRUG

hydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline

Also known as: crystalline insulin
Insilin
salineOTHER

hydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline

Also known as: normal saline
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis in remission

You may not qualify if:

  • active Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Hassanien

Asyut, Assuit, 71111, Egypt

RECRUITING

MeSH Terms

Interventions

hylaseHyaluronoglucosaminidaseInsulinSodium ChlorideSaline Solution

Intervention Hierarchy (Ancestors)

Glycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyasesProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Manal Hassanien, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Hassanien, MD

CONTACT

01062679200manal_hassanien@yahoo.com

Abdelraheem Elawamy, MD

CONTACT

01000032655arawamyyy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigaror

Study Record Dates

First Submitted

December 25, 2017

First Posted

January 9, 2018

Study Start

July 1, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

July 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

after complete recruiting of patients

Shared Documents
STUDY PROTOCOL
Time Frame
1 year

Locations

EG(1)