Randomized clinical trial ozone therapy on protruded lumbar disc herniation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170727035336N1

Enrollment

100

Registered

2017-12-31

Start date

2016-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the nervous system. Nerve, nerve root and plexus disorders

Interventions

Intervention 1: Injection of 250 micrograms of ozone in the disk space between the prosthetic disk Break the nucleotide proteoglycan so that the water is removed from the disk and the disk is collecte

Treatment - Drugs

Injection of 250 micrograms of ozone in the disk space between the prosthetic disk Break the nucleotide proteoglycan so that the water is removed from the disk and the disk is collected

Oral administration of a non-steroidal anti-inflammatory drug Naproxen 500 mg every 12 hours and bacullofen 10 mg muscle relaxant every 12 hours for 2 weeks

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The amount of analgesic use. Timepoint: 2 weeks, 3 and 6 months after treatment. Method of measurement: Based on the dose of analgesic.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Reza Javaheri MD

Tabriz University of Medical Sciences

javaherir@tbzmed.ac.ir+98 41 3334 0830

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026