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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

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT03742466

First Posted

November 10, 2018

Last Updated

August 4, 2020

Sponsor

Assiut University

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

Studies a U.S. FDA-regulated Device Product

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

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

Learn more about this trial

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

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