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

NCT ID: NCT03394131

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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

Conditions

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Treatment Resistant Carpal Tunnel in RA Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hyalase

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

Group Type EXPERIMENTAL

Hylase

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

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

Insilin

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

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

Interventions

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Hylase

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

Intervention Type DRUG

Insulin

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

Intervention Type DRUG

saline

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

Intervention Type OTHER

Other Intervention Names

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Hyaluronidase crystalline insulin normal saline

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis in remission

Exclusion Criteria

* active Rheumatoid arthritis
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manal Hassanien

principle investigaror

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hassanien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Manal Hassanien

Asyut, Assuit, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Manal Hassanien, MD

Role: CONTACT

01062679200

Abdelraheem Elawamy, MD

Role: CONTACT

01000032655

Facility Contacts

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Manal Hassanien, MD

Role: primary

01062679200

Abdelraheem Elawamy, MD

Role: backup

01000032655

Other Identifiers

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Hydrodissection of CT in RA

Identifier Type: -

Identifier Source: org_study_id

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