Lumbosacral Radiculopathy due to Lumbar Intervertebral Disc Protrusion (L4-L5 or L5-S1).This study focuses on chronic low back pain (LBP) with radicular symptoms, aiming to improve pain management and functional outcomes for patients with this condition.. Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy
Conditions
Interventions
Intervention 1: Intervention Group:Group B (Steroid + Ozone Group):This group will receive the same steroid injection as the control group, with the addition of ozone gas.Injection Details:Steroid Com
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 70 years Diagnosed with low back pain (LBP) with radicular symptoms lasting more than three months and unresponsive to medical therapy, rest, and physical therapy Magnetic resonance imaging (MRI) evidence of lumbar intervertebral disc protrusion at the L4-L5 or L5-S1 levels
Exclusion criteria
Exclusion criteria: History of spinal fractures, inflammatory diseases, malignancy, or facet joint syndrome. Previous spinal surgeries uncontrolled diabetes mellitus neuropathy spondylolisthesis extruded discs severe knee osteoarthritis (grade 4), scoliosis clinical or laboratory evidence of infection Coagulopathy symptoms of cauda equina syndrome symptoms of cauda equina syndrome neurological disorders severe systemic diseases, mental illnesses current anticoagulant therapy Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain IntensityMeasurement Method: Visual Analog Scale (VAS)Scale Range: 0 (No Pain) to 10 (Worst Pain Imaginable)Objective: To assess the patient's pain intensity before and after the intervention to determine treatment efficacy.Measurement Time Points: Baseline, 1 month, and 6 months post-injection. Timepoint: Pain IntensityMeasurement Method: Visual Analog Scale (VAS)Scale Range: 0 (No Pain) to 10 (Worst Pain Imaginable)Objective: To assess the patient's pain intensity before and after the intervention to determine treatment efficacy.Measurement Time Points:Before intervention (Baseline)1 month post-injection3 months post-injection6 months post-injection? The measurement time points are clearly specified.? The measurement method and scale range are explicitly stated. Method of measurement: Pain IntensityMeasurement Method: Visual Analogue Scale for PainMeasurement Tool: Visual Analogue Scale Ruler for PainScale Range: 0 (No Pain) to 10 (Worst Pain Imaginable)Objective: To assess the patient's pain intensity before and after the intervention to determine treatment efficacy.Measurement Time Points:Before the intervention (Baseline)One month after injectionThree months after injectionSix months after injection.;Functional Disability. Timepoint: Before the intervention (Baseline)One month after injectionThree months after injectionSix months after injection. Method of measurement: Measurement Method: Oswestry Disability IndexMeasurement Tool: Oswestry Disability Index QuestionnaireUnit of Measurement: Percentage of functional disability caused by low back painObjective: To assess the effect of treatment on patients' functional ability and reduction of limitations caused by pain Measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life. Timepoint: Time Points:Before the intervention (Baseline)One month after injectionThree months after injectionb Six months after injection. Method of measurement: Measurement Method: World Health Organization Quality of Life Questionnaire Measurement Tool: World Health Organization Quality of Life Questionnaire – Short Version (26 Questions)Unit of Measurement: Quality of life score based on participants' responses. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNima Amiresmaili
Tehran University of Medical Sciences
Outcome results
None listed