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A comparison of the efficacy of low-volume versus high-volume injection of epidural steroids in the management of back pain

A comparison on the efficacy of low volume versus high volume injection of epidural steroids in the management of back pain and radiculopathy associated with lumbar degenerative disc disease - A Randomised superiority clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051441
Enrollment
154
Registered
2023-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue Health Condition 2: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: Caudal epidural steroid injection: The first group (Low volume group) will be treated with a dose of 80 mg triamcinolone in a 3 ml solution Duration of intervention : 30 minutes Contro

Sponsors

Government medical college Kozhikode
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged 25-50 Years), capable of providing consent and complying with the outcome instruments 2. Single-level lumbar disc herniation diagnosed by MRI 3. Lower lumbar disc herniation diagnosed by MRI (L4/L5 or L5S1). 4. Signs and symptoms consistent with the nerve root irritation 5. Patients with lumbar radicular pain, irrespective of neurological signs. 6. Patients have refractory pain, even after treatment with NSAIDs, opioids, and/or physical therapies for more than two weeks duration. 7. Failure after a minimum of 6 weeks of conservative treatment

Exclusion criteria

Exclusion criteria: Patientâ??s reluctance and lack of compliance, does not provide informed consent for the study 2. Patients with previous back surgery at the affected segmental level and radiologically proven facet syndrome 3. Multiple level lumbar disc herniation diagnosed by MRI 4. Patients with a severe motor deficit, segmental instability, spinal deformities. 5. Any systemic infection or local infection at the injection site 6. Patients presenting with cauda equina syndrome 7. Patients on anticoagulation therapy or having any bleeding disorder 8. Patients with congestive heart failure or uncontrolled blood sugars 9. Pregnant females or ongoing breastfeeding females 10. Patients with underlying malignancy 11. Patients are not excluded based on the duration of pain alone. 12. Patients who are allergic to any component of the medicine?

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of low volume corticosteroid injections in the treatment of low back pain and radiculopathy associated with lumbar degenerative diseases with that of conventional high-volume injection.Timepoint: 1. Pre injection 2. Post injection At 3 weeks, 6 weeks, and 3 months

Secondary

MeasureTime frame
To compare the side effects, if any, of low-volume versus high-volume corticosteroid injections in the treatment of low back pain.Timepoint: During the injection and in the next 24 hours after the injection

Countries

India

Contacts

Public ContactRaju Karuppal

Govt. Medical College Kozhikode

drrajuortho@rediffmail.com

Outcome results

None listed

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