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A study to compare the efficacy of steroid plus local anaesthetic and only local anaesthetic in epidural space for management of chronic low back pain due to herniated intervertebral disk.

A comparative study of epidural steroid with local anaesthetic and only local anaesthetic injection in management of chronic low back pain due to herniated disk: a prospective randomised controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009080
Enrollment
44
Registered
2017-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: Epidural local anaesthetic plus steroid.: 9 ml of 0.25% bupivacaine and 1ml (40 mg) methylprednisolone acetate will be given in caudal epidural space under fluroscopic guidance. Control

Sponsors

ESI Institute of Pain Management ESI Hospital Sealdah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from low back pain due to herniated disk with or without radiculopathy 2. Duration of low back pain more than 12 weeks 3. Patient taking antineuropathic medicine more than 4 weeks 4. Degree of pain more than 5 according to numeric rating scale

Exclusion criteria

Exclusion criteria: 1. Patients presenting with a cauda equina syndrome, severe paresis, severe pain 2. History of trauma, spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy 3. Ongoing treatment with non-steroidal anti-inflammatory drugs 4. Body mass index of more than 30 5. Poorly controlled psychiatric conditions with possible secondary gain or severe comorbidity. 6. Severe intraspinal pathology (large disc herniations occupying more than 50% of the spinal canal, spinal stenosis, tumours, bleeding, dural fistula, synovial cysts, or dysraphia). 7. Patients not giving consent.

Design outcomes

Primary

MeasureTime frame
Pain score using Numeric rating scaleTimepoint: prior to the procedure and 1, 4 and 6 weeks after the procedure.

Secondary

MeasureTime frame
Functional disability index by the Roland-Morris Disability QuestionnaireTimepoint: prior to the procedure and 1, 4 and 6 weeks after the procedure.

Countries

India

Contacts

Public ContactDr Subrata Goswami

ESI Institute of Pain Management

drsgoswami@gmail.com9830430430

Outcome results

None listed

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