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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
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107559
Enrollment
198
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Sponsors

AIIMS Patna
Lead Sponsor

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

MeasureTime frame
To measure proportion of patients who will achieve more than or equal to 30 percent reduction in verbal rating pain scale (VRS, 0-100) at 3 months from base line in both groupsTimepoint: Baseline and 3 months

Secondary

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

Countries

India

Contacts

Public ContactAshutosh Singh

All India Institute Of Medical Sciences, Patna

amarjeetdmch@gmail.com9570890646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026