The effect of Oxygen-ozone and corticosteroid therapy for the treatment of Carpal tunnel syndrom

Phase 3

Recruiting

Conditions: carpal tunnel syndrome.
Mononeuropathy in diseases classified elsewhere

Registration Number: IRCT20151017024572N15

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Cavernous carpal tunnel syndrome confirmed by Electrodiogenesis (EDX) criteria
Severe moderate carpal tunnel syndrome that is proven by EDX criteria
The presence of paresthesia or numbness in the median nerve pathway
Unwillingness of the patient to undergo surgery
SNAP amplitude decrease
NCV across wrist smaller than 40 m/sec
Peak SNAP latency larger than 3.6 msec
CMAP latency larger than 4.2 msec

Exclusion Criteria

The presence of severe atrophic symptoms or severe CTS in EMG-NCV.
Contraindications for corticosteroid injection such as corticosteroid allergy and injection site infections
CTS treatment with surgery or corticosteroid injection in the last 6 months
Traumatic or neoplastic origin of symptoms
Not having satisfaction for injection
CMAP amplitude absence (CMAP) or the presence of symptoms of fib / psw in tense muscles
Signs of Cervical Activated Radiculopathy in Nidal Electromigraphy or Extruded Cervical Discs in MRI

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score based on Visual Analogue Scale. Timepoint: Before injection, 2 weeks and 8 weeks after injection. Method of measurement: Visual Analogue Scale.;The functional limitations and symptoms severity scales on Boston Questionnaire. Timepoint: Before injection, 2 weeks and 8 weeks after injection. Method of measurement: Boston Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Clinical Global Impression Questionnaire.;Patient Global Impression of Improvement. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Patient Global Impression of Improvement Questionnaire.;Electromyographic findings. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Nerve strip.;Median nerve cross section. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography.;Channel depth. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography.;Flexor Retinaculum Thickness. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography.