ُEfficacy of Insulin Versus Hyalase Hydro-dissection of M... | NCT03394131

Studies
ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

NCT03394131

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 13, 2018Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Treatment Resistant Carpal Tunnel in RA Patients

Interventions

Hylase
Insulin
saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

Aug 1, 2018Estimated

First Submitted Date

Dec 25, 2017

First Submission Date that Met QC Criteria

Jan 3, 2018

First Posted Date

Jan 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2018

Last Update Posted Date

Jul 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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 of median nerve inside CT twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of CT

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hylase	Drug	hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline	Hyalase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain intensity	Visual analog scale 0-100	6 months

Secondary Outcomes

Measure	Description	Time Frame
nerve conduction	sensory velocity	6 months
ultrasound	cross sectional area	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rheumatoid arthritis in remission

Exclusion Criteria:

active Rheumatoid arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manal Hassanien, MD	Contact	01062679200		manal_hassanien@yahoo.com
Abdelraheem Elawamy, MD	Contact	01000032655		arawamyyy@yahoo.com

Overall Officials

Name	Affiliation	Role
Manal Hassanien, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manal Hassanien	Recruiting	Asyut	Assuit	71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

after complete recruiting of patients

Types

Study Protocol

Time Frame

1 year

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C021430	hylase
D006821	Hyaluronoglucosaminidase
D007328	Insulin
D012965	Sodium Chloride
D000077330	Saline Solution

Ancestor Terms

ID	Term
D006026	Glycoside Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes

Browse Leaves

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Browse Branches

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