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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742466
• Other study ID #: 17300356
• Status: Completed
• Phase: N/A
• Start date: November 10, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Chronic Pain
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Syndrome

Intervention

Drug:
• Ozone
After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25µg/ml) will be performed under sonographic guidance
• 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

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in median nerve conduction parameters	distal motor latency	6 months