Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Sodium Hyaluronate
ultrasound
Sodium Hyaluronate and 1% lidocain
Corticosteroid and 1%lidocain
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring hydrodissection, sodium hyaluorinate
Eligibility Criteria
Inclusion Criteria:
- patients with mild or moderate carpal tunnel diagnosed by nerve conduction study
Exclusion Criteria:
- secondary carpal tunnel to any other disease and peripheral neuropathy patients
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
sodium hyaluorinate ultrasound guided
corticosteroid with ultrasound guided
Arm Description
median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided
median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided
Outcomes
Primary Outcome Measures
neuropathic pain VAS
0-10 VAS scale in the 2nd week after injection
Secondary Outcome Measures
nerve conduction study
motor nerve conduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03180125
Brief Title
Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study
Official Title
Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
March 15, 2019 (Actual)
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
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT.
Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.
Detailed Description
60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
hydrodissection, sodium hyaluorinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sodium hyaluorinate ultrasound guided
Arm Type
Experimental
Arm Description
median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided
Arm Title
corticosteroid with ultrasound guided
Arm Type
Placebo Comparator
Arm Description
median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
hyalgan
Intervention Description
median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
ultrasound guided injection
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate and 1% lidocain
Intervention Description
injection in the carpal tunnel
Intervention Type
Drug
Intervention Name(s)
Corticosteroid and 1%lidocain
Intervention Description
injection in the carpal tunnel
Primary Outcome Measure Information:
Title
neuropathic pain VAS
Description
0-10 VAS scale in the 2nd week after injection
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
nerve conduction study
Description
motor nerve conduction
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
(Likert scale) with the grade 1 means that the patient's satisfaction was 30% ,grade 2, the patient's satisfaction was 30-50%,grade 3 ,the satisfaction was 50-80% ,and grade 4 was 80%, Grades 3 and 4 were defined as "overall satisfied
Time Frame
1month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with mild or moderate carpal tunnel diagnosed by nerve conduction study
Exclusion Criteria:
secondary carpal tunnel to any other disease and peripheral neuropathy patients
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study
We'll reach out to this number within 24 hrs