Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients
Primary Purpose
Carpal Tunnel Syndrome, Chronic Pain, Scleroderma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ozone
methylprednisolone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- adult patients with scleroderma
- complaining of carpal tunnel syndrome of 3-month duration or more
- diagnosed axonal neuropathy using electrodiagnosis, nerve conduction study
Exclusion Criteria:
- patient refusal
- infection at the site of intervention
- previous injection in the recent 3 months
- Coagulopathy
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ozone
methylprednisolone acetate
Arm Description
After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
Outcomes
Primary Outcome Measures
to assess pain alleviation through the visual analog scale (VAS)
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
Secondary Outcome Measures
Changes in median nerve conduction parameters
distal motor latency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03742466
Brief Title
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients
Official Title
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
September 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Carpal tunnel syndrome is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent local ozone therapy could offer symptom improvement in scleroderma patients with Carpal tunnel syndrome
Detailed Description
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.
Scleroderma patients are a special group which usually sufferers from such problem
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Chronic Pain, Scleroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozone
Arm Type
Active Comparator
Arm Description
After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
Arm Title
methylprednisolone acetate
Arm Type
Active Comparator
Arm Description
After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
Intervention Type
Drug
Intervention Name(s)
Ozone
Intervention Description
After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
Intervention Type
Drug
Intervention Name(s)
methylprednisolone acetate
Intervention Description
After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
Primary Outcome Measure Information:
Title
to assess pain alleviation through the visual analog scale (VAS)
Description
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in median nerve conduction parameters
Description
distal motor latency
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients with scleroderma
complaining of carpal tunnel syndrome of 3-month duration or more
diagnosed axonal neuropathy using electrodiagnosis, nerve conduction study
Exclusion Criteria:
patient refusal
infection at the site of intervention
previous injection in the recent 3 months
Coagulopathy
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients
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