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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03742466

Enrollment

Registered

2018-11-15

Start date

2018-11-10

Completion date

2019-09-30

Last updated

2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Chronic Pain, Scleroderma

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

Interventions

DRUGOzone

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

DRUGmethylprednisolone 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Changes in median nerve conduction parameters	6 months	distal motor latency

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026