Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2018
CompletedStudy Start
First participant enrolled
November 10, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedAugust 5, 2020
August 1, 2020
9 months
November 10, 2018
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (1)
Changes in median nerve conduction parameters
6 months
Study Arms (2)
Ozone
ACTIVE COMPARATORAfter prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
methylprednisolone acetate
ACTIVE COMPARATORAfter prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
Interventions
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
Eligibility Criteria
You may qualify if:
- adult patients with scleroderma
- complaining of carpal tunnel syndrome of 3-month duration or more
- diagnosed axonal neuropathy using electrodiagnosis, nerve conduction study
You may not qualify if:
- patient refusal
- infection at the site of intervention
- previous injection in the recent 3 months
- Coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emad Zarief Kamel Said
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of Anesthesia, ICU, and pain
Study Record Dates
First Submitted
November 10, 2018
First Posted
November 15, 2018
Study Start
November 10, 2018
Primary Completion
July 30, 2019
Study Completion
September 30, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share