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

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ClinicalTrials.gov Identifier: NCT03742466

Recruitment Status : Completed

First Posted : November 15, 2018

Last Update Posted : August 5, 2020

Sponsor:

Information provided by (Responsible Party):

Emad Zarief , MD, Assiut University

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

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome Chronic Pain Scleroderma	Drug: Ozone Drug: methylprednisolone acetate	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial
Actual Study Start Date :	November 10, 2018
Actual Primary Completion Date :	July 30, 2019
Actual Study Completion Date :	September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Systemic scleroderma Carpal tunnel syndrome

MedlinePlus related topics: Carpal Tunnel Syndrome Ozone Scleroderma

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma Localized Scleroderma Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Roussy Levy Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ozone After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance	Drug: Ozone After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
Active Comparator: methylprednisolone acetate 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 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

Outcome Measures

Primary Outcome Measures :

to assess pain alleviation through the visual analog scale (VAS) [ Time Frame: 6 months ]
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 [ Time Frame: 6 months ]
distal motor latency

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742466

Locations

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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111

Sponsors and Collaborators

Assiut University

More Information

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Responsible Party:	Emad Zarief , MD, Associate professor of Anesthesia, ICU, and pain, Assiut University
ClinicalTrials.gov Identifier:	NCT03742466
Other Study ID Numbers:	17300356
First Posted:	November 15, 2018 Key Record Dates
Last Update Posted:	August 5, 2020
Last Verified:	August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Carpal Tunnel Syndrome Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Syndrome Chronic Pain Disease Pathologic Processes Pain Neurologic Manifestations Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases	Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Connective Tissue Diseases Skin Diseases Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics

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