A study to determine the efficacy of ozone injection in the intervertebral disc space (A method of management for long-standing low back pain).

Comparison of Intradiscal Ozone and Epidural Steroid with Local Anesthetic Injection and Intradiscal Ozone Injection alone in Patients with Lumbar Disc Herniation: A Prospective Observational Study

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/07/044158

Enrollment

Registered

2022-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M512- Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from low back pain due to disc herniation with or without radiculopathy. 2. Duration of pain more than 3 months with inadequate pain relief after conservative management for more than 6 weeks. 3. Pain score of more than equals to 5 on NRS 11 point scale. 4. Protruded disc from L1-S1 level with grade I-III disc degeneration with adequate water content as seen in T2 weighted MRI of L-S spine. 5. Absence of prior spine interventions.

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Coagulopathy and/or patients on anticoagulants. 3. Infection at site of injection. 4. Hypersensitivity to local anaesthetic and/or radiographic contrast agent. 5. Evidence of significant sensory or progressive motor deficit with or without bowel/bladder dysfunction. 6. Presence of anatomical deformity of spine e.g. scoliosis, kyphosis etc. 7. Evidence of severe psychiatric illness. 8. Presence of extruded and/or sequestered disc with grade IV-V disc degeneration on MRI. 9. History of previous back surgery or implant insertion, tumour, herniation compressing more than 50% of spinal canal and synovial cysts. 10. Presence of multiple sclerosis, cardiac pacemaker and pregnancy.

Design outcomes

Primary

Measure	Time frame
More than 50% pain relief according to pain score using Numerical Rating Scale or NRSTimepoint: 3 weeks, 2 months and 3 months after the procedure.	—

Secondary

Measure	Time frame
Improvement in functional disability calculated by MODQ (Modified Oswestry Disability Questionnaire) according to Oswestry Disability Index Version 2.1aTimepoint: 3 weeks, 2 months and 3 months after the procedure.	—

Countries

India

Contacts

Public ContactDr Gargi Nandi

ESI Institute of Pain Management

drgarginandi@gmail.com9433813886

Outcome results

None listed

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