Randomized clinical trial ozone therapy on protruded lumbar disc herniatio
Phase 3
Recruiting
- Conditions
- Diseases of the nervous system.Nerve, nerve root and plexus disordersG50,G51,G5
- Registration Number
- IRCT20170727035336N1
- Lead Sponsor
- Vice chancellor for research, Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Acute low back pain with radiculopathy and the presence of a moderate to severe (5-10cm) Visual Analog Scale (VAS) on one leg and MRI indicating a protruded disc without degenerative disc
Exclusion Criteria
Extruded discs, clinical signs of radiculopathy (reduction of tendon reflexes, muscle weakness, sensory impairment), horse tail syndrome, progressive neurological deficits, spinal cord stenosis. Spondylolisthesis, Previous Surgery; Diabetic Neuropathy , Body mass index greater than 30, lower back scoliosis more than 20 degrees; Lower limb length difference of more than 1.5 centimeters in simple radiography; pregnancy; and favism in which ozone therapy is contraindicated.Patients who have recently received ozone therapy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in pain intensity and basal test before and after treatment of ozonotherapy. Timepoint: 2 weeks, 3 and 6 months after treatment. Method of measurement: Clinical evaluation will be performed by the VAS (Pain Observation Scale).
- Secondary Outcome Measures
Name Time Method The amount of analgesic use. Timepoint: 2 weeks, 3 and 6 months after treatment. Method of measurement: Based on the dose of analgesic.