Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial

Conditions
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Carpal Tunnel Syndrome, Chronic Pain, Scleroderma

Intervention / Treatment
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* Drug: Ozone
* Drug: methylprednisolone acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozone<br>After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance | Drug: Ozone<br>* After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance<br>|
| Active Comparator: methylprednisolone acetate<br>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 | Drug: methylprednisolone acetate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in median nerve conduction parameters | distal motor latency | 6 months |