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effect of ozone on low back pain.

Not Applicable
Conditions
low Back Pain.
low Back Pain with Sciatica
Registration Number
IRCT201610177984N26
Lead Sponsor
Vice chansellor for research, Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
64
Inclusion Criteria

Inclusion criteria including: Radicular LBP that persistent more than 6 weeks; Root impression due to disc bulging or foraminal narrowing that confirmable in MRI; The patient age must be between 18 -70 yr old; Physical status level I to II according to ASA physical status classification system. Valid, written consent to participate in study must be obtained; Pain score must be more than 4 according to numerical rating scale(NRS)tool; Lack of pain relieve to medication and physical therapy; Three or less nerve root must be involved.
Exclusion criteria including: If coagulopathy to exist; presence of systemic or zone of needle entry point infection; Severe anatomical distortion(for example scoliosis); presence history of back surgery or device implantation; Severe psychotic disorder is co-exist; history of allergy to local anesthetics is positive; if progressive deficiency or motor deficit to exist; If malignancy, pregnancy, or history of substance abuse, HIV and /or chronic hepatitis marker positive to exist; If acute trauma; or cauda equina syndrome to exist.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain. Timepoint: befor itervention will started,and the end of weeks two and four months three and six. Method of measurement: Nnmrical Rating Scale tool of pain.;Chronic pain biomarker, TNFalpha in serum. Timepoint: befor itervention will started,and the end of month two. Method of measurement: Venous Blood sample.;Root Impression in MRI. Timepoint: Before intervention and the end of second month. Method of measurement: MRI imagine.
Secondary Outcome Measures
NameTimeMethod
Disability. Timepoint: befor intervention will start,the end of weeks two and four,months three and six. Method of measurement: Oswestry Disability Questionnaire.;Labratory data, BUN, Cr, Bs. Timepoint: befor intervention will start,the end of weeks two and four,months three and six. Method of measurement: Venous blood sample.;Dermatomal pain distribiotion,posetive SLR(and degree of), revres SLR. Timepoint: before intervention will start,the end of weeks two and four,month three and six. Method of measurement: Pain that induced with physical examination and it's distribution,degree of range of motion that induced pain,.
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