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

July 12, 2018 updated by: Manal Hassanien, Assiut University

Treatment of Carpal Tunnel in Rheumatoid Arthritis

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

Study Overview

Status

Unknown

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71111
        • Recruiting
        • Manal Hassanien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid arthritis in remission

Exclusion Criteria:

  • active Rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hyalase
injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided
Drug: Hylase
hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline
Other Names:
  • Hyaluronidase
PLACEBO_COMPARATOR: Placebo
injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided
Other: saline
hydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline
Other Names:
  • normal saline
ACTIVE_COMPARATOR: Insilin
injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided
Drug: Insulin
hydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline
Other Names:
  • crystalline insulin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

December 25, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (ACTUAL)

January 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hydrodissection of CT in RA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

after complete recruiting of patients

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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