Back to resultsُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients
Primary Purpose
Treatment Resistant Carpal Tunnel in RA Patients
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hylase
Insulin
saline
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Carpal Tunnel in RA Patients
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis in remission
Exclusion Criteria:
- active Rheumatoid arthritis
Sites / Locations
- Manal HassanienRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Hyalase
Placebo
Insilin
Arm Description
injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided
injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided
injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided
Outcomes
Primary Outcome Measures
pain intensity
Visual analog scale 0-100
Secondary Outcome Measures
nerve conduction
sensory velocity
ultrasound
cross sectional area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03394131
Brief Title
ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients
Official Title
Treatment of Carpal Tunnel in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Carpal Tunnel in RA Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyalase
Arm Type
Experimental
Arm Description
injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided
Arm Title
Insilin
Arm Type
Active Comparator
Arm Description
injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided
Intervention Type
Drug
Intervention Name(s)
Hylase
Other Intervention Name(s)
Hyaluronidase
Intervention Description
hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
crystalline insulin
Intervention Description
hydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline
Intervention Type
Other
Intervention Name(s)
saline
Other Intervention Name(s)
normal saline
Intervention Description
hydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline
Primary Outcome Measure Information:
Title
pain intensity
Description
Visual analog scale 0-100
Time Frame
6 months
Secondary Outcome Measure Information:
Title
nerve conduction
Description
sensory velocity
Time Frame
6 months
Title
ultrasound
Description
cross sectional area
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis in remission
Exclusion Criteria:
active Rheumatoid arthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Hassanien, MD
Phone
01062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelraheem Elawamy, MD
Phone
01000032655
Email
arawamyyy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Phone
01062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name & Degree
Abdelraheem Elawamy, MD
Phone
01000032655
Email
arawamyyy@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after complete recruiting of patients
IPD Sharing Time Frame
1 year
Learn more about this trial
ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients
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