Does Adding Hypertonic Saline Improve Pain Relief in Spine Injections for Lower Back Nerve Pain? A Clinical trial.

Efficacy of adjuvant 3 percent hypertonic saline in transforaminal epidural steroid injection in lumbosacral radiculopathy: A randomised clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109771

Enrollment

198

Registered

2026-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: G544- Lumbosacral root disorders, not elsewhere classified

Interventions

Intervention1: 3 Percent Hypertonic Saline: 2.5 ml 3 percent hypertonic saline added to 0.5 percent Levobupivacaine 0.5ml and Triamcinolone 40mg Control Intervention1: Normal Saline: 2.5 ml 0.9 percen

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients having chronic lower back pain with unilateral leg pain with radiculopathy, who failed conservative therapy (Analgesic drug and physiotherapy) 2. Patients having corresponding site of lesion in MRI

Exclusion criteria

Exclusion criteria: 1. Patients having coagulopathy, local infection at injection site. 2. Patients having known hypersensitivity to study drugs 3. Pregnant or Lactating patients 4. Patient who underwent prior spine surgery at the affected level 5. Patients having severe neurological deficit or Cauda Equina syndrome

Design outcomes

Primary

Measure	Time frame
To compare proportion of patients who will achieve more than or equal to 30% reduction in verbal rating pain scale (VRS, 0-100) at 3 months from base line between two groupsTimepoint: Baseline and 3 months	—

Secondary

Measure	Time frame
To compare proportion of patients who will achieve more than or equal to 30% reduction in VRS (0-100) at 1 month and 6 monthsTimepoint: 1 month and 6 month;To Assess improvement in Oswestry Disability Index at 1, 3 and 6 monthsTimepoint: 1 month, 3 month and 6 months;To compare proportion of patients who will improve by at least 15% from baseline in VRS pain and ODI scores at 1, 3, 6 monthsTimepoint: 1, 3 and 6 months;To compare total pre procedure and post procedure analgesic requirementTimepoint: 3 months	—

Measure

Time frame

To compare proportion of patients who will achieve more than or equal to 30% reduction in VRS (0-100) at 1 month and 6 monthsTimepoint: 1 month and 6 month;To Assess improvement in Oswestry Disability Index at 1, 3 and 6 monthsTimepoint: 1 month, 3 month and 6 months;To compare proportion of patients who will improve by at least 15% from baseline in VRS pain and ODI scores at 1, 3, 6 monthsTimepoint: 1, 3 and 6 months;To compare total pre procedure and post procedure analgesic requirementTimepoint: 3 months

—

Countries

India

Contacts

Public ContactAshutosh Singh

All India Institute Of Medical Sciences Patna

dramarjeetk@aiimspatna.org9570890646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026