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Trial record 11 of 22 for:    "Nerve Compression Syndrome" | "Hormones"

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

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ClinicalTrials.gov Identifier: NCT03742466
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Completion Date : September 30, 2019


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




Primary Outcome Measures :
  1. 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 :
  1. Changes in median nerve conduction parameters [ Time Frame: 6 months ]
    distal motor latency



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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

Information from the National Library of Medicine

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


Contacts
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Contact: Emad Z kamel, M.D. +201007046058 emadzarief@yahoo.com

Locations
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Egypt
Emad Zarief Kamel Said Recruiting
Assiut, Egypt, 71111
Contact: Emad Z Kamel, M.D.    +201007046058    emadzarief@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Emad Zarief , MD, Associate professor of Anesthesia, ICU, and pain, Assiut University
ClinicalTrials.gov Identifier: NCT03742466     History of Changes
Other Study ID Numbers: IRB00009922
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
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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Nerve Compression Syndromes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Carpal Tunnel Syndrome
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Syndrome
Chronic Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Connective Tissue Diseases
Skin Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate