To know the effectiveness of addition of 3% hypertonic saline to steroid injection which is injected in lower back for pain management in patients with chronic low backache.

Effect of adjuvant hypertonic saline in Transforaminal Epidural Steroid injection for the management of patients with chronic lumbosacral radiculopathy: A double blind, prospective, randomized trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081064

Enrollment

Registered

2025-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: M545- Low back pain

Interventions

Intervention1: 3% hypertonic saline: 2ml of 3% hypertonic saline mixed with 1ml of 1% lignocaine and 20mg of triamcinolone injected using proper aseptic precautions via transforaminal epidural injecti

Eligibility

Inclusion criteria

Inclusion criteria: Patients with unilateral lumbosacral radicular pain of more than 3 months duration ASA class 1 and 2 patients consenting for the study

Exclusion criteria

Exclusion criteria: Patients not consenting for the study Known hypersensitivity to local anesthetic Patient having an infection at the site of intervention Patients on anticoagulation therapy Patients lost to follow up before 3 month evaluation Patients with untreated psychiatric illness that would interfere with pain perception and assessment Patients with symptomatic cardiac and respiratory diseases History of spine surgery or trauma to spine

Design outcomes

Primary

Measure	Time frame
Reduction in the mean NRS (Numerical Rating Scale) score compared with baselineTimepoint: 3 months	—

Secondary

Measure	Time frame
Reduction in the mean NRS (Numerical Rating Scale) after 24 hours, 48 hours and 1 month compared with baselineTimepoint: 24 hours, 48 hours and 1 month;Reduction in the mean Oswestry Disability Index (ODI) score at 3 and 6 months compared with baselineTimepoint: 3 months and 6 months;Global Perceived Effect (GPE) measured using 7 point Likert scale for satisfaction at 3 and 6 monthsTimepoint: 3 months and 6 months;Incidence of adverse eventsTimepoint: 6 months	—

Measure

Time frame

Reduction in the mean NRS (Numerical Rating Scale) after 24 hours, 48 hours and 1 month compared with baselineTimepoint: 24 hours, 48 hours and 1 month;Reduction in the mean Oswestry Disability Index (ODI) score at 3 and 6 months compared with baselineTimepoint: 3 months and 6 months;Global Perceived Effect (GPE) measured using 7 point Likert scale for satisfaction at 3 and 6 monthsTimepoint: 3 months and 6 months;Incidence of adverse eventsTimepoint: 6 months

—

Countries

India

Contacts

Public ContactDr Christopher Dass

All India Institute of Medical Sciences, New Delhi

christopherdass25@gmail.com9560177416

Outcome results

None listed

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