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Completed

NCT Number: NCT03742466

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

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

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Key information

Conditions

Carpal Tunnel Syndrome Chronic Pain Connective Tissue Diseases Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sprains and Strains Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozone

Drug

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

Methylprednisolone Acetate

Drug

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 outcomes

  1. to assess pain alleviation through the visual analog scale (VAS)

    Time frame: 6 months

    visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary outcomes

  1. Changes in median nerve conduction parameters

    Time frame: 6 months

    distal motor latency

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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