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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Scleroderma; Chronic Pain
• Interventions: Drug: methylprednisolone acetate; Drug: Ozone

• Registration Number: NCT03742466
• Lead Sponsor: 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

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 Timeline

• Study Start: 2018-11-10
• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Primary Completion: 2019-07-30
• Study Completion: 2019-09-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone acetate	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
Ozone	Ozone	After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance

Primary Outcome Measures

Name	Time	Method
to assess pain alleviation through the visual analog scale (VAS)	6 months	visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary Outcome Measures

Name	Time	Method
Changes in median nerve conduction parameters	6 months	distal motor latency

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt