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CompletedNCT03742466Updated Aug 5, 2020

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

An interventional study of Ozone and methylprednisolone acetate in Carpal Tunnel Syndrome, Chronic Pain and Scleroderma, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study 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

Read the 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

02

Conditions studied

03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patient refusal
  • infection at the site of intervention
  • previous injection in the recent 3 months
  • Coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Ozone

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

    Drug: Ozone

  • Active comparator
    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

    Drug: methylprednisolone acetate

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. Changes in median nerve conduction parameters

    distal motor latency

    Time frame: 6 months

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Study locations

1 site
  • Emad Zarief Kamel Said
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03742466
Lead sponsor
Assiut University
Responsible party
Emad Zarief , MD (Associate professor of Anesthesia, ICU, and pain, Assiut University) — Principal investigator
First posted
Nov 15, 2018
Start date
Nov 10, 2018
Primary completion
Jul 30, 2019
Completion
Sep 30, 2019
Last update
Aug 5, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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