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

Assiut University

Status: Completed

Conditions: Scleroderma; Chronic Pain; Carpal Tunnel Syndrome

Treatments: Drug: Ozone; Drug: methylprednisolone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03742466

17300356

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Ozone

Active Comparator group

Description:

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

Treatment:

Drug: Ozone

methylprednisolone acetate

Active Comparator group

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

Treatment:

Drug: methylprednisolone acetate