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

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ClinicalTrials.gov Identifier: NCT03394131
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, Assiut University

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

Condition or disease Intervention/treatment Phase
Treatment Resistant Carpal Tunnel in RA Patients Drug: Hylase Drug: Insulin Other: saline Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Carpal Tunnel in Rheumatoid Arthritis
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : May 1, 2018
Estimated Study Completion Date : August 1, 2018


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 Name: 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 Name: 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 Name: crystalline insulin




Primary Outcome Measures :
  1. pain intensity [ Time Frame: 6 months ]
    Visual analog scale 0-100


Secondary Outcome Measures :
  1. nerve conduction [ Time Frame: 6 months ]
    sensory velocity

  2. ultrasound [ Time Frame: 6 months ]
    cross sectional area



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis in remission

Exclusion Criteria:

  • active Rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394131


Contacts
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Contact: Manal Hassanien, MD 01062679200 manal_hassanien@yahoo.com
Contact: Abdelraheem Elawamy, MD 01000032655 arawamyyy@yahoo.com

Locations
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Egypt
Manal Hassanien Recruiting
Assiut, Assuit, Egypt, 71111
Contact: Manal Hassanien, MD    01062679200    manal_hassanien@yahoo.com   
Contact: Abdelraheem Elawamy, MD    01000032655    arawamyyy@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Manal Hassanien, MD Assiut University

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Responsible Party: Manal Hassanien, principle investigaror, Assiut University
ClinicalTrials.gov Identifier: NCT03394131     History of Changes
Other Study ID Numbers: Hydrodissection of CT in RA
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after complete recruiting of patients
Supporting Materials: Study Protocol
Time Frame: 1 year

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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
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs